chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect reported; The patient was inadvertenlty administered a dose of MMRII via the intramuscular route rather than the recomended subcuataneous; The dose of MMRII was reconstituted with expired diluent; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHA (recombinant human albumin), lot # N032752, expiration date 20-NOV-2019 (exact dose was not reported) via the intramuscular route instead of the recommended subcutaneous route, for prophylaxis. The vaccine was reconstituted with an expired sterile diluent (STERILE DILUENT), with lot # M041689  has been verified to be a valid lot number for sterile diluent, expiration date reported as 20-JUN-2019, but upon internal validation established as 29-JUN-2019.  There were no adverse effects reported.
possible expired dose;Three doses were left out at ambient room temperature past there beyond use date; sore arm; headache; fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible expired dose;Three doses were left out at ambient room temperature past there beyond use date), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and FATIGUE (fatigue) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible expired dose;Three doses were left out at ambient room temperature past there beyond use date), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and FATIGUE (fatigue). On 12-Apr-2021, EXPIRED PRODUCT ADMINISTERED (possible expired dose;Three doses were left out at ambient room temperature past there beyond use date) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.    This case was linked to MOD21-075517, MOD21-075500, MOD21-074055, MOD21-075351, MOD21-075527, MOD21-075540, MOD21-075544, MOD21-075549 (E2B Linked Report). This case was linked to MOD-2021-076892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up information included patient's initials.; Sender's Comments:  MOD21-075517:Cross linked case MOD21-075500:Cross linked case MOD21-074055:Cross linked case MOD21-075351:Cross linked case MOD21-075527:Cross linked case MOD21-075540:Cross linked case MOD21-075544:Cross linked case MOD21-075549:Cross linked case
Didn´t get the 2nd dose due to the pandemic shutdowns; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.       Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received 1st dose of shingrix and due to pandemic shutdown the patient did not received 2nd dose. Additional Supportive Information: The patient did not received 2nd dose of shingrix due to pandemic shutdown which led to social problem.
Swelling, redness, hot to touch, upper arm to elbow and into chest area. Couldn't wear tight fitting clothing soreness.
Swollen face; Swollen lips; Very itchy eyes; Hives on the back; A spontaneous report  was received from a nurse concerning a 36 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen face,  swollen lips, very itchy eyes and hives on the back(Intervention/Medically Important).  The patient's medical history included cataract surgery, bilateral eye surgery and COVID. The patient had giant tear left and buckles in bilateral eyes.  Concomitant medications included seroquel (200mg), zoloft 50mg (50 mg), Topamax (100mg bid), Latuda (80mg), birth control, tylenol, advil and tizanidine (as needed) drugs used for unknown indication.  On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Jan 2021, the patient experienced swollen face, swollen lips, very itchy eyes and hives on the back.  Lab test was performed on 26 Jan 2021, tryptase level was 8.4.  Treatment for the events include Epipen for both legs, pepcid and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, swollen face, swollen lips, very itchy eyes and hives on the back, were considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
difficulty sleeping; Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (difficulty sleeping) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old). On an unknown date, the patient experienced INSOMNIA (difficulty sleeping). At the time of the report, INSOMNIA (difficulty sleeping) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided.  2 siblings had received a dose of the Moderna COVID-19 vaccne bivalent on 21 Oct 2022 with lot number 017H22A and expiration date 29 May 2023 who were under 6 years old. Both had difficulty sleeping since receiving these doses of the vaccine. No additional doses, medications had been administered since that error.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662624 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662624:Patient-1 case
Fatigue, chills, headaches a few hours after dosage. Spending a lot of time resting, taking aspirin and vitamin D3
bloody noses; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bloody noses), FATIGUE (fatigue) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (medical history was not provided).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EPISTAXIS (bloody noses), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, EPISTAXIS (bloody noses), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non Significant follow-up
Confusion, Hallucinations, Headache, Sedation, Palpitations, Tachycardia, chest pain;numbness Narrative:  Approximately 1 hour post first Covid Moderna Vaccine patient went to emergency room with chest pain, numbness in arms racing heart, flushing and she was given prednisone, benedryl iv steroids iv remdesivir iv sent home on prednisone
PATIENT WAS VACCINATED TODAY WITH HPV VACCINATION. AFTER VACCINE, PATIENT HAD SYNCOPAL EPISODE WHILE ATTEMPTING TO STAND FROM TABLE AFTER VACCINATION. HE FELL APPROX 3-4 FEET FROM EXAM TABLE AND HIT POTERIOR SCALP ON FLOOR (CONCRETE WITH OVERLYING VINYL). PATIENT DID NOT LOSE CONCIOUSNESS. BP AT TIME OF EVENT 128/84 HR 70S. PT C/O SEVERE HEADACHE, AND NAUSEA AFTER EVENT. PEERLA. ICE PACK APPLIED AND REFERRED TO ER FOR FURTHER EVAL AND TX. SENT BY PRIVATE VEHICLE. DENIED DIZZINESS, CHEST PAIN, SOB AFTER EVENT.
MY PSA HAD INCREASED PRIOR TO MY VACCINATIONS AND INCREASED AGAIN AFTER MY TWO MODERNA VACCINATIONS.  MY UROLOLGIST MENTIONED THAT THEY WERE SEEING APSA INCREASE ON SOME PATIENTS AFTER COVID VACCINATION.  I AM BEING TREAT FOR ENLARGED PROSTATE AND UNDER EVALUATION FOR THE INCREADED PSA VALUES.
Mom reports child had soreness & swelling in both arms; Seen in Hlth Ctr apparent allergic rxn to insect bite on inner aspect of rt arm & lt arm, swollen, reddish-blue, & hot tender to touch;
Information has been received from a pharmacist concerning a 40 year old female with a shellfish allergy who was vaccinated with a dose of Gardasil. The patient was scheduled to be administered another unspecified vaccination. Subsequently the patient developed an unspecified allergic reaction. The patient was examined at the local emergency room, At the time of the report the patient's outcome was unknown. Additional information has been requested.
43 yr old female employee presented to employee health clinic for H1N1 influenza vaccination injection. Immediately after the pt c/o tingling to right cheekbone, throat and eye. there was no SOB or tongue swelling.  She was given diphenhydramine 25mg po X 1 at 10:15am and at 12 noon her symptoms were resolved. No SOB or difficulty breathing.
States that she had continual itching from 45 minutes after injection on Mon until Fri 11/19, she states the itching was at the site, arm and chest on left, no other areas affected, she denies fever, chills, redness or aching, she did not take any medication for itching
Information has been received from a licensed practical nurse via a company representative referring to a 7 years old male patient. The patient's medical history, concurrent condition and concomitant medication were not reported. On 29-JAN-2019 the patient was vaccinated with the first dose of VARIVAX and on 25-FEB-2019 was received the second dose (dose, route, lot # and expiration date were unknown) for prophylaxis, which was too close together. No adverse effect was reported.
I woke and the right side of my face was paralyzed for 2 months. I was diagnosed with Bell's Palsy.
Pt had 4th DTAP shot on 4/6/2000 and had a shock episode early AM of 4/11/2000, resulting in damaged brain tissue and inablility to move left side of body. Had high-pitched crying and occasional hypnotic states.
Facial tingling, facial itching, throat swelling (within 30 mins of vaccine administration)
Information has been received from a registered nurse concerning her son who on an unspecified date was vaccinated with the first 0.5 ml dose of MMR II. The nurse reported that the patient was given MMR II at 15 months of age and later developed a measles like rash at the injection site. The patient was brought to his doctor who verified that it was a measles like rash. On an unspecified date the patient recovered from measles like rash. Follow up information has been received from a registered nurse concerning her 14 month old child (also reported as 15 month old) with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, who on 22-SEP-2009 received the first dose of MMR II (Lot # 664315/0483Y), SQ. Concomitant therapy included a fourth dose of Hib conj vaccine (Lot # 657704/1437U), IM, in the left thigh given on 22-SEP-2009. It was reported that on 25-SEP-2009 an adverse reaction was diagnosed at the clinic as: no contagious form of measles. Measles like rash all over his body lasted approximately one week and started 2-3 days after shot. It was initially only at the injection site, then all over his body. The patient recovered on an unspecified. date. Additional information is not expected.
Tiredness, Headache, Muscle pain, Chills, Fever, Nausea over course of 36 hours; headache came back after a gap of 7 hours and persisted for 7.5 hours.
A blotchy, erythematous, scaling rash spread across shoulders, upper chest and arms over a period of about 1 week. Since then, the rash has remained stable. Mild pruritis is noted. No fever or systemic symptoms. No laoratory results available at this time
This case was reported by a other health professional and described the occurrence of throat swelling in a male patient who received flu vaccine. On an unknown date, the patient received flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving flu vaccine, the patient experienced throat swelling. On an unknown date, the outcome of the throat swelling was unknown. It was unknown if the reporter considered the throat swelling to be related to flu vaccine. Additional information received: Pharmacy school student reporting a case she was assigned involved a male patient who received a flu vaccine and experienced his throat swelling up. She has no other details, other than what she provided during conversation.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 40-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were
Fever, bruising on left arm and left leg, fatigue. Went to urgent care, drew labs, low blood count, went to ER. Was given steroids and several plasma transfusions. Was sent home with steroids.
vertigo; condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and CONDITION AGGRAVATED (condition aggravated) in a 61-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo) and CONDITION AGGRAVATED (condition aggravated). At the time of the report, VERTIGO (vertigo) and CONDITION AGGRAVATED (condition aggravated) had not resolved. Not Provided          No concomitant medications was provided by the reporter.  No treatment information was reported.   This case was linked to MOD-2021-083465 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Outcome of the event was updated to not recovered.
First dose of vaccine (10/29/21 to 11/05/2021):    10/29/21  3:07PM: Got the jab Night: Swollen and pain on injection site 10/30/21  PM: Started tingling all over the body 10/31/21  Noon: Started tingling and pinching on feet and ankles when walking Night: Felt Left breast harden and swollen 11/01/21 8AM: Sudden fast heart beat while keeping still &  a little bit tight feeling on the chest 11/02/21 Injection site felt back to normal 11/04/21 No longer felt Left breast harden and swollen 11/05/21 Still have tingling, fast heart beat   * So far, did not go to hospital due to no dizziness or serious short of breath, and did not know how much it would cost if go to the hospital to check out.
I GOT THE NORMAL ACHYNESS I USUALLY GET WITH COVID SHOTS IT WAS A BIT WORSE THE FIRST NIGHT THAN USUAL I THAN STARTED GETTING GRADUALLY WORSE AND WORSE I FINALLY QUIT THINKING IT WOULD GET BETTER AND WENT TO THE HOSPITAL URGENT CARE MAY 15TH. THEY TOOK A LOT OF BLOOD TESTS AND GAVE ME NO TREATMENT
About 24 hours after receiving my second dose, I became extremely fatigued.  I had trouble finishing my work day.  When I went home I went straight to the Lazy Boy.  Was too tired to fix any supper for a couple hours.  Then I ate and rested another 2 hours before I felt OK.
Pt had an adverse exp following vax w/Hep B vax; no further details were provided;
Woke up to itchy injection site 9 days after 1st Moderna dose. Throughout the day, it's itched and grown into a large welt, size of a baseball. Warm to touch and itchy are biggest issue. Annoying more than painful.
vasculitis-like rash w/edema of both legs; rx Pred, off work; t97.6; BP 150/90, P76, R20
I suffered an apparent seizure according to the multiple pharmacists working that day. It happened within less than a minute of the injection. I went to sit down to be monitored and the next thing I know is I have a pharmacist in my face asking me if I am ok and telling me an ambulance was on the way. No idea what caused it or how severe the seizure was.
Patient hospitalized for cesarean section within 6 weeks of receiving COVID vaccination. Both patient and baby had an uncomplicated hospitalization.
sore, aching arm which has continued to date. Referred for physical therapy due to shoulder impingement.  Began physical therapy in early June 2003 and continuing treatment.
Not sure it's truly adverse but she does have a larger than usual red area - most of her upper arm, slightly raised knot at area of injection, no issue lifting arm, the area is warm and red, husband just concerned and wanted it reported. She said she felt warm and tired last night went to bed early.  Area is sore.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age. Nurse reported that unspecified number of improperly stored RECOMBIVAX HB, (lot # not reported). Doses had been administered to unspecified number of patients. Vaccines were exposed to 50F for 48 hours. No adverse effects reported. This is one of several reports from the same reporter source. Additional information is not expected.
Chronic diarrhea,  started more than 8 hours after vaccination and ongoing for 3 weeks and 5 days, treated with Imodium and hyoscyamine
Pt originally called with mild arm soreness and back soreness on 11/04 and 11/05 and began to feel better on 11/06 but on 11/07 he had chills, loose stools, and a temp of 37.6 degrees Celsius. Pt did take some ALEVE at this time that seemed to help. On 11/09 I spoke with the pt again via telephone and he was experiencing some fatigue and fever of 101. Able to eat and drink, denied any swelling, SOB, abd pain, or any other symptoms. On 11/11/2017 1140 AM spoke with pt via telephone. Pt states he continues to have headache, myalgias and fever. Pt states his fever was 101.9. Pt states he has been taking TYLENOL q 6 hours and ALEVE q 12. Pt states the fever will resolve originally with the TYLENOL but then comes back. Pt denies any lack of appetite, abdominal pain, n/v/d, cough, swelling of the tongue, mouth or lips, or any rashes. Pt states his wife who had the exact same vaccines is feeling fine. Pt states he is eating and drinking Gatorade. Pt states his fatigue is worsening, he states he feels like he doesn't want to get out of bed today. Pt states he is usually very active. I then consulted a colleague and called him back later on 11/11 and pt stated he thinks his fever broke around 1330 has he was sweating a lot and then has not had a fever since. Pt states he still feels very week. Pt adv to follow up with PCP if symptoms do not resolve by Monday to rule out any underlying conditions. I called again on 11/13 to see how pt was doing and pt stated he ended up going to the hospital on 11/11/2017 and has been admitted ever since. Pt states they are running tests and doing investigation.