chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received first dose on 04-Feb-2021 and second dose on 14-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 04-Feb-2021 and second dose on 14-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A, 029L20A, 939903 and 005M2A9) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Ibuprofen (Sulfa Ibuprofen). Past adverse reactions to the above products included Allergy with Ibuprofen. Concurrent medical conditions included Asthma, Allergy (Allergies) and Solitary kidney (one kidney). Concomitant products included MELOXICAM from 01-Jan-2021 to an unknown date for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 04-Feb-2021 and second dose on 14-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 04-Feb-2021 and second dose on 14-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Currently the patient is of 76 years.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment information was reported.
Had it, even with the shot/Suspected vaccination failure; Had it four times; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient received shingles shots and still experienced shingles four times. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
lost consciousness for a brief period; doing something that looked like a small seizure; got tunnel vision; vasovagal response; feel faint, dizzy, and lightheaded; feel very weak; This is a spontaneous report from a contactable consumer (patient).  A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at 14:30 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EP7524. Medical history included periodontal surgery. Concomitant medications included spironolactone, adapalene, benzoyl peroxide (Epiduo Forte), azelaic acid (FINACEA), aciclovir, hydrocortisone (Xerese). The patient believed she experienced some kind of vasovagal response. On 13Apr2021 at 08:00, the patient got up from sleeping and went to the restroom, where she started to feel faint, dizzy, and lightheaded. The patient sat down and got tunnel vision and she started to feel very weak but regained her vision after sitting. The patient was helped back to bedroom but had to stop and sit in the floor where patient lost consciousness for a brief period, less than 10 seconds. Her partner said patient was doing something that looked like a small seizure. The patient had had this response before many times when giving blood and even after her periodontal surgery. The patient was recovering from the events.
The vaccine was administered 32 days after it was removed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered 32 days after it was removed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was administered 32 days after it was removed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered 32 days after it was removed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
On 08/20/21 had physical....Dr. said I was in good health....was given the shingles and what she said was tetanus but turned out to be Tdap vaccine...felt sick few hours later, sluggish, fever went to 102.8 that night....throughout weekend was feeling sick at times, nausea, temps was fluctuating but was going as high as 101.9 at times . Mon 08/23/21 approximately 1:30pm ...fever above 101 , felt sick at house...sweating profusely, ...nausea....Wife called telenurse...advise to go to ER. After arriving at ER got progressively worse, placed on oxygen. Troponin number was elevating ...was transferred to Medical Center by ambulance. 08/23-08/25 was in cardiology. Several tests done. Diagnosed with Acute Viral Myocarditis.
Persistent rash appeared on both arms in AC space. Resolved after first dose. After second dose rash returned "much worse".  Rash has no purulent drainage. Pt tx with 60mg prednisone per day for 5 days.
Vaccine was recieved on December 15.  Body movement and motion different. Left leg pain. Dec 22nd ER visit due to entire body pain. Jan 6  Discovered My mother dead on the floor due to stroke.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 51.53.  Concomitant products were not provided.  On 28-Feb-2021, at excursion time 09 AM, temperature was 27 and at excursion time 01 PM, temperature was 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 28-Feb-2021, vials were stored in cooler 1, following are the time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 PM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43, and 4 PM: 45 for batch number 014M20A.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt states she fainted outside while walking her dog "many hours after the vaccine in 90 plus degree weather."
This case was reported by a healthcare professional and described the occurrence of deltoid pain in an 27-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  Concurrent medications included Ibuprofen (Advil), Paracetamol (Tylenol) and Cold medication.  Following previous influenza vaccinations (unknown manufacturer), the subject's arm felt tingly but it went away 4-5 hours after the shot was administered.  Subject also experienced minor soreness for a couple of days.  See GSK case A0698837A for details.  On 26 October 2007 the subject received 1st dose of Flulaval (.5 ml, left arm).  On 26 October 2007, within 2 hours after vaccination with Flulaval, the subject experienced pain to movement in deltoid.  That same day she also experienced pain in arm on lifting heavy objects and pain when moving arm above her or behind her.  The following day she experienced arm stiffness in the morning.  At an unspecified time during the week of 18 November 2007, she experienced a cold.  The subject did consult with a physician regarding the events.  At the time of reporting the arm stiffness, pain lifting heavy objects and pain when moving arm above or behind her had improved.  The pain in the deltoid area was unresolved.  The outcome of the cold was unspecified.  The facility received two lots of vaccine and they were not certain which lot number this Flulaval came from.  The two lot numbers are AFLLA0533AA and AFL1A0075AA.
Systemic: Extreme pain in left leg (8 on pain scale), starting 1 week after shot, limited mobility due to pain in limb. Pain began to subside in about another week and then numbness from the knee to thigh began-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Pt has had a hx of surgery in left arm, no arm problems after shot. 1 week s/p vaccine extreme pain in left leg began, limiting mobility. Pain brokethu APAP extra stregnth, and cycles of icing/heating/elevation. 1 week after pain sx, pain began to subside but numbness from the knee and thigh began. Pt is following up with her orthopedic MD. Pt states there has been no preceding injury in the leg.
PATIENT GET MODERNA DOSE 1 AND DOSE 2. PT SUPPOSE TO GET DOSE 3 MODERNA, HOWEVER, PATIENT GET PFIZER,  PATIENT IS FINE AFTER THE SHOT, NO ADVERSE EVENT REPORT.
Very tired at 10pm. Woke up at 1am in severe pain all over body- skin, muscles  and joints.  Mild Sore throat and headache. Very  weak and hard to walk without feeling faint.  Felt horrible all day until about 7-8 pm.
9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. As1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended).    Patient age was reported as 1 year and 4 months.  No concomitant product use was reported.  HCP stated the temperature happed on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.   No symptoms were reported after the administration of the vaccine.  No treatment information was provided.   This case was linked to MOD-2022-624878 (E2B Linked Report).; Sender's Comments:  MOD-2022-624878:Master case
Narrative: 70 yo M received dose #2 of the Moderna COVID-19 vaccine on 3/19/2021 (Lot#: 038A21A; Exp Date: 09/02/2021) around 15:30. Pt reports to provider during appointment on 4/1/20221 symptoms of nausea and headache ongoing for one year. Originally contacted health care system on 3/16/2021. Pt reports ongoing nausea at baseline and sinus headaches at baseline however these symptoms worsened after vaccination. Reaction classified as mild as no intervention/treatment required.
Neck is stiff; Upper back is stiff; No appetite; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck is stiff), MUSCULOSKELETAL STIFFNESS (Upper back is stiff), DECREASED APPETITE (No appetite), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Back surgery (9 screws in her back) in November 2019 and Acupuncture on 16-Feb-2001.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck is stiff), MUSCULOSKELETAL STIFFNESS (Upper back is stiff), DECREASED APPETITE (No appetite), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck is stiff), MUSCULOSKELETAL STIFFNESS (Upper back is stiff) and FATIGUE (Fatigue) outcome was unknown and DECREASED APPETITE (No appetite) and NAUSEA (Nausea) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-071303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071303:1st dose vaccine
I was at work was asymptomatic in the morning then by 11:30AM I decided to go home to not get anyone else sick. I started getting a sore throat that same day. This is my second time having COVID this year and it feels like flu-like. I had congestion and runny nose. Also had an earache. The medicine the provider gave me is helping a lot. It is getting better. The urgent care wants me to follow up with my provider.
Awoke with stabbing, severe sore throat, runny nose. No fever. Next day better but felt exhausted & breathless for 1 wk. Worried about heart. Went to Dr & was told sx's (no local reaction at site of injection). Has heart text set for today.
Bordered edema, rash and pain down the arm and across the chest within 24 hours and 6 days after the vaccine was given.
Approx. 2 x 3 in erythematous/indurated wheal to (L) upper out arm. Mometasone applied in clinic 20/2 DEPOMEDROL/DECADRON IM, Hydroxyzine Rx.
Patient received vaccine at age 17.  Will not receive 2nd dose until age 18 at our site.
Systemic: nausea and flush-Mild, Systemic: Vomiting-Medium, Additional Details: patient looked whitish/pale in the face, requested pt to stay a few more minutes, gave him water, he then vomitted a moderate amount, after resting and vomitting, patient stated he felt better. called on 11/28/2022 as a follow up for patient. left message.
This case was reported by a other health professional via call center representative and described the occurrence of photosensitivity in a 49-year-old female patient who received FLUARIX QUADRIVALENT (batch number BT7Ag, expiry date 18th June 2015). Previously administered products included flu vaccine. Concurrent medical conditions included drug allergy (Allergy to LIPITOR) and drug allergy (Allergy to Atenolol). Concomitant products included Aspirin (Baby), CRESTOR, fish oil, Vitamin D3 and phenobarbital. On 30th October 2014, the patient received FLUARIX QUADRIVALENT (injection) .5 ml. On 30th October 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced photosensitivity. On an unknown date, the outcome of the photosensitivity was recovered/resolved. It was unknown if the reporter considered the photosensitivity to be related to FLUARIX QUADRIVALENT. Additional information received: The patient experienced sensitivity to light following the administration of the Flu vaccine. She stated that her sensitivity was to LED and Fluorescent light. The sensitivity lasted for about 2 to 3 months.
Developed large erythematous local reaction from shoulder to elbow, which developed on night of and morning after vaccine. No systemic symptoms. resolved within 24-48 hrs.
Pts right arm had redness swelling and pain at injection site. It is improving but is not yet 100%better
The mother states the child developed a seizure on 2/3/01 and 5 seizures on 2/6/01. States she took child to hospital where she was treated and tested. MD informed mother not to get DTP again.
Vial was punctured May 7; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was punctured May 7) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021 at 10:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was punctured May 7). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Vial was punctured May 7) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-132324 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Additional information include reporter details updated, patient demographics and second dose details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132324:Same reporter
pt recvd vax; 24 hrs later exp fever, muscle aches & shakes;
The only difference was fever blisters around mouth and in nose...regular side effects lasted about 24 hrs, fever blisters formed that evening through today 03/28/21
Presented to clinic on 7/22/06 with c/o HA, fever and Dry NPC. Temp 100.3. Reported pain to the back of his neck. Had received smallpox vaccine on 7/13/06. Smallpox vaccination site with erythema and warmth. Diagnoses with smallpox reaction. Ordered to quarters for 48 hours. Tylenol 325mg 1 or 2 po every 4-6 hours as needed.
pt recv vax & c/o dizziness as needle was being removed p/2nd inj;pt immed fainted;pt was placed in chair & had sz lasting approx 15-20sec;pt revived p/approx 1min c/o nausea no vomiting, h/a, weakness;mom & pt left p/30min & went to PMD;
chicken pox; rash; pain; nerve pain; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included neuropathy.   On 14th September 2020, the patient received Shingrix. On an unknown date, 4 weeks after receiving Shingrix, the patient experienced chickenpox, rash, pain and nerve pain. The patient was treated with pregabalin and gabapentin. On an unknown date, the outcome of the chickenpox and rash were recovered/resolved and the outcome of the pain and nerve pain were not recovered/not resolved.   The reporter considered the chickenpox, rash, pain and nerve pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported receiving the SHINGRIX vaccine and approximately 4 weeks later got chicken pox and a rash.  Also, stated that about 5 weeks after the vaccination his rash went away.   The patient stated that he had neuropathy in the past and now he had pain and nerve pain that will not go away.   The patient stated he tried taking Pregabalin and Gabapentin but it did not help. The patient consented to follow up.
11:30  Reports throat dryness s/p vaccination, during 15 minute monitoring; "throat feels restricted" w/no additional complaints Po hydration/ water given, 02 via NRM applied, continued monitoring;  NAD, respirations unlabored;  BP 140/90  P 65 RR 14   O2SAT 99%RA 11:45  "feels better";  BP 140/89  P 63  RR 14  O2 SAT 98% RA;  released from facility w/ daughter
pt passed out about 2 minutes after receiving vaccine. Pt was seated when he lost consciousness, pt was initially disoriented but was fully conscious and lucid within seconds. Pt stated that he did not hit head when falling from chair, blood pressure was normal at two separate readings minutes after the incident, pt was sweaty with loss of color but was more embarrassed than anything, wife and son returned from shopping, pt felt much better and left with his wife approximately 30 minutes after receiving the vaccine.  A follow-up call 4 hours after the event was made. Pt stated he was at work and felt fine.
Pt said she felt dizzy, was told to lay down, passed out, put a cold rag on her, gave her a popsicle, felt better. We sat her back up after a few minutes she said that she felt dizzy again, we laid her back down, said she couldn't hear anything, we then gave her some crackers. She began to feel better, we did have her call a friend to come and get her. Pt said she had not eaten all day.
Severe infection / cellulitis at injection site in left shoulder and arm. Redness, swelling, hot to the touch, 101.2 fever, rash.