chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It's past 42 days since she received her 1st dose/patient received her 1st dose on May 31st; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It's past 42 days since she received her 1st dose/patient received her 1st dose on May 31st   ) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It's past 42 days since she received her 1st dose/patient received her 1st dose on May 31st   ). On 31-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It's past 42 days since she received her 1st dose/patient received her 1st dose on May 31st   ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient reported that she did not see any severe adverse effect. She also stated that she did not come to work because she was very busy so she delayed second dose.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information contains significant info added Second Dose information provided and event coding updated.
After the 2nd dose  - the next day had soreness in arm, the next day the lymph  notes on my left neck, shoulder and armpit was swelling lasted a few days. The chest pain started 4 weeks after , pain in my chest on 26Nov2021 and wasn't too concerned but the next morning, had virtual appointment. Doctor prescribed an inhaler thinking its a muscular skeletal problem. Chest pain still there. after 30Nov, went to primary care in person and was diagnosed chest wall pain syndrome. With J&J - I had a immune response - the following day I felt achy  , low energy and a cold virus
19 patients received an expired booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received includes patient Information.
This patient broke out in a itchy rash similar to 1st reaction. In addition she cried continuously for 2 hours. No local induration. She was advised to take Benadryl.
After two days of receiving first dose I woke up Saturday morning with ringing in right ear and was muffled with some hearing loss. Test proved some hearing loss in right ear due to viral infection. (I was not sick before the vaccine.) Went to ENT and prescribed me steroids. Taking them for two weeks. Hopefully pain and ringing subsides!
tinnitus/my husband has the same problem like I have; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus/my husband has the same problem like I have".  Additional Information: Caller stated that, after receiving third shot she experienced tinnitus and she confirmed that her husband also experienced the adverse event. Caller also informed that, another patient also had stop to hearing and also he has noise.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A consumer reported that an 8 year old female pt received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 11/28/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 11/28/03.  Dose regimen was 1 dose 1 time per day (IN).  No concomitant medications or vaccines were administered.  On 11/30/03, the pt developed nasal congestion and a minor sore throat due to drainage.  On 12/05/03, the pt developed green nasal discharge.  The reporter indicated that the pt's health care professional has been notified.  The pt has not recovered.  No additional information was available at the time of this report. Additional information received on 09-Jan-2004 from the family nurse practictioner provided additional adverse event informaton. On the same day, she was examined by a family nurse practicioner. Upon physical examination temperature was 97.8 deg. F.; blood pressure 102/60, the ears "looked fine", there was mild to moderate nasal congestion, scant postnasal drip, no cervical lymphadenopathy; clear bilateral breath sounds, and unlabored breathing. The nurse stated the patient had "very little in the way of" a nonproductive cough and there had been no fever. The patient denied headache. A diagnosis of viral upper respiratory infection was made. Treatment included pusing fluids; a trial of Robitussin (guaifenesin/dextromethorphan) was suggested.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0471321A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (CODANE), Drug allergy (DANES DEMEROL) and Tetanus.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided   This case was linked to MOD-2021-313106 (Patient Link).
2ND COVID19 VACCINE ADMINISTERED 4/13/2021. ADMITTED TO MEDICAL CENTER ON 08/06/2021 WITH COVID PNEUMONIA AND ACUTE HYPOXIC RESPIRATORY FAILURE. WAS TREATED WITH REMDESEVIR IV, DEXAMETHASONE, AND PLACED ON HIGH FLOW O2. PATIENT DECOMPENSATED, WAS PLACED ON BIPAP, AND THEN TRANSFERRED TO ICU AND INTUBATED. CONTINUED TO HAVE INCREASING VENTILATORY SUPPORT. FAMILY EVENTUALLY REQUESTED COMFORT-FOCUSED CARE. EXTUBATED AND EXPIRED ON 8/18/2021.
Itchy throat. Narrative: Examined by Dr. BENADRYL 25mg oral given and sensation throat itching resolved.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 24-APR-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (dose and route not reported) that was 24 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Patient became light-headed and dizzy after admin of the shot, during the 15min monitoring period.  No meds admin'd to treat the reaction at this clinic.  Pt brought to emergency department
This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. No information regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies was provided. On 07-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 13-DEC-2017, the patient received the second dose of ZOSTAVAX (exact dose, route of administration, lot# and expiration date were not reported). No adverse symptoms were reported.
pt recvd vax & devel a high fever of 102-103 & had a sz 1 wk following 3rd immun;
1 month post vaccination patient still has a knot at the injection site which she reported as getting larger, and she is unable to sleep on the affected side (left).  She is currently out of town, so she was instructed to follow up with a local provider to assess the situation.  She has had a knot since the vaccine was administered.
Patient came in on 6/3/04 to be seen.  The patients mother states that the child recieved her 5 yr old immunizations on 6/2/04.  According to mother, there were 3 injections given in patient's left thigh.  Patient was seen by physician and was found to have localized swelling, redness measuring 10x5cm, and tenderness to palpation.  She also had an oral fever of 101 F.  The treating doctor prescribed Augmentin, Benedryl, and cool compress application.
Redness, edema and itching at the injection site.  The employee took Benadryl and all symptoms resolved.
Intense shivering through the night post-inoculation with slight fever; soreness and tired the following day such that I didn't go in to work.
01/11/22 presents to ED for "MS exacerbation after being diagnosed with COVID-19". PMHx of "MS (relapsing remitting) and seizure disorder"
Individual received first dose of the Moderna vaccine on December 28,2020 and second dose of Moderna on January 28, 2021.  Individual did not receive vaccines at, vaccines were administered through City.  Individual tested positive for  SARS-CoV-2 on today.
Developed T- 101, 11/12/08. No hardness and erythema about 50 cent size to injection site.
Fatigue; gave three doses from one expired vial/ Vaccine given 1 day past expiration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave three doses from one expired vial/ Vaccine given 1 day past expiration) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus since 25-Aug-2019, Fibromyalgia since 30-Oct-2017 and GERD since 14-May-2019. Concomitant products included EPINEPHRINE (EPIPEN) for Allergic reaction, DIAZEPAM (VALIUM) and HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for Anxiety, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and IBUPROFEN for Pain, CLOTRIMAZOLE (LOTRIMIN [CLOTRIMAZOLE]), CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), GABAPENTIN (NEURONTIN), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), MELOXICAM (MOBIC), MONTELUKAST SODIUM (SINGULAIR), RANITIDINE HYDROCHLORIDE (ZANTAC), ECONAZOLE NITRATE (SPECTAZOLE), NALOXONE, TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) and OMALIZUMAB (XOLAIR) for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave three doses from one expired vial/ Vaccine given 1 day past expiration). On an unknown date, the patient experienced FATIGUE (Fatigue). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (gave three doses from one expired vial/ Vaccine given 1 day past expiration) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  No temperature excursion of vial was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant follow-up received on 05-AUG-2021 and contains new information that are patient's height, weight, ethnicity, Medical History, and event, that is fatigue.
Patient states that red, itchy rash developed at injection site during evening of 6-13-13. Became progressively larger to diameter of baseball as of 6-16-13. Patient saw MD 6-17-13, rash improving.
Cl reports redness, swelling, warmth below injection site left arm and referred to urgent care.
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 23-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Body started aching around 4pm on 2/4/21.  Woke up with a 101.5 degree fever at 2am on 2/5/21. Had a fever all day. Fever fell down to 100.2. Still have a slight fever of 100 on 2/6/21.  Starting to feel better.
On Sunday morning, I developed ringing my left ear with muffled hearing.  Hearing loss progressed.
fractured her pelvis; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient fractured her pelvis just days before she was to have her second dose of the Pfizer vaccine. The patient passed the 6-week deadline for taking the second dose, 10 weeks ago as of this writing. The reporter hasn't been able to find information in the web that says a second dose should still be pursued under such circumstances. Outcome of the event was unknown.  Information about batch/lot number has been requested.
administration past expiry date, 6 days of the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration past expiry date, 6 days of the expiration date) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration past expiry date, 6 days of the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration past expiry date, 6 days of the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  Date of administration of vaccine was reported as 04-Apr-2022 and 05-Apr-2022. No treatment information was provided.  The vial was initially stored in the refrigerator: It was stored in the freezer, thawed on the day of administration. The vial did not undergo any temperature excursions.
Extrem fatigue, severe swelling upper arm - top of shoulder - left side of neck and left eye. Headache, pain entire left side of body ( arm, shoulder, leg, foot ). On 12062021 shot of antihistamine and cortisone from doctor. Swelling went down some. Pain better, still fatigued.
just a gas; stomach pain is not that bad; little headache; sore arm; little tired; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (just a gas), ABDOMINAL PAIN UPPER (stomach pain is not that bad), HEADACHE (little headache), PAIN IN EXTREMITY (sore arm) and FATIGUE (little tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain.    On 11-Feb-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 FLATULENCE (just a gas), ABDOMINAL PAIN UPPER (stomach pain is not that bad), HEADACHE (little headache), PAIN IN EXTREMITY (sore arm) and FATIGUE (little tired). At the time of the report, FLATULENCE (just a gas), ABDOMINAL PAIN UPPER (stomach pain is not that bad), HEADACHE (little headache), PAIN IN EXTREMITY (sore arm) and FATIGUE (little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take Pain Medicines for back pain as a Concomitant medication.
lost balance for a moment; dizziness; felt little lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost balance for a moment), DIZZINESS (dizziness) and DIZZINESS (felt little lightheaded) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced BALANCE DISORDER (lost balance for a moment), DIZZINESS (dizziness) and DIZZINESS (felt little lightheaded). At the time of the report, BALANCE DISORDER (lost balance for a moment), DIZZINESS (dizziness) and DIZZINESS (felt little lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided    This case was linked to US-MODERNATX, INC.-MOD-2021-089650, US-MODERNATX, INC.-MOD-2021-089661 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089661:Reporter case US-MODERNATX, INC.-MOD-2021-089650:Reporter case
COVID; Didn't got the vaccine before the 37 day mark; Got a negative reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION COMPLICATION (Got a negative reaction to the vaccine). On 31-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Didn't got the vaccine before the 37 day mark). On an unknown date, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization). The patient was hospitalized on 19-Jan-2021 due to COVID-19. On 31-Mar-2021, INCOMPLETE COURSE OF VACCINATION (Didn't got the vaccine before the 37 day mark) had resolved. At the time of the report, COVID-19 (COVID) and VACCINATION COMPLICATION (Got a negative reaction to the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       18-Jan-2021, the patient had a negative reaction to the mRNA-1273 (Moderna COVID-19 Vaccine). The next day, she had to go to the hospital and was there for about a week. She had a bad cough/a terrible cough and all the symptoms that "are expected".  She then tested positive for COVID a few days after vaccination.   This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
left Sub clavicle swelling, limited range of motion in neck; left Sub clavicle swelling, limited range of motion in neck; This is a spontaneous report from a contactable other health care professional, the patient. An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 12Feb2021 as dose number unknown, single for covid-19 immunization. Medical history reported as none. The patient concomitant medications were not reported. On 12Feb2021 21:45, the patient experienced left sub clavicle swelling and limited range of motion in neck. The therapeutic measures were not taken for the reported events. The patient did not receive any other vaccine in four weeks and also did not receive other medications in two weeks. The did not have covid prior to vaccination and not tested for covid post vaccination. There possible known allergies were present, but it was unspecified. The patient visited the doctor or other healthcare professional office for the events. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
I got the vaccine at 11am on 1/19/21 by 8pm of 1/19/21 I had a low grade temp and was tired so I went to bed. By 1am I woke up with uncontrollable shivering and had an alarming temperature of 104. I then took alternating Tylenol and ibuprofen and for the next 24 hours and I had a continuous fever for the entirety of 1/20/21 that would range from 101-103 with taking  the constant Tylenol and ibuprofen.  In addition I had shooting nerve pain down my legs, I was so weak I felt like I could not move, terrible body aches, and had what felt like dizziness and blurred vision at the same time. By 1/21/21 I started to improve but still had an increased temp of 99 and body aches but not as bad as the day prior. I am a healthy 38 year old with a good BMI no medical history and am very concerned about the temperature of 103-104 in regards to those with underlying heart or health conditions which may not be able to withstand that high of a temperature or a continuous temperature like I had for an extended period of time . I would have gone to the emergency room but I am a healthcare professional with the education and experience to know what to do in this situation