chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the vaccine and during the observation/waiting period, Pt was sitting near the pharmacy consultation window. She got up to tell me she wasn't feeling well and collapsed. She was awake and aware when I reached her seconds after she went down and reported dizziness and nausea. She laid down on a bench in the pharmacy and had some cold water and an instant cold pack over about 30 minutes. She declined an ambulance and called her husband to drive her home. The dizziness remained for the duration but she reported it was not worsening.
Pt had brief feeling of dizziness, lightheadedness and hot face/neck area. I provided the patient with a bottle of water, offered a cold compress (pt declined) and monitored the patient for approximately 20-30 minutes after onset of symptoms. Patient recovered, felt good and left.
Left arm sore, swelling. Went to urgent care, was prescribed cephalexin and prednisone for cellulitis.
Had 3 shingles vaccines, had shingles/Suspected vaccination failure; Had 3 shingles vaccines, had shingles; Had 3 shingles vaccines; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 26-June-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had three shingles vaccines and then had the worst case of shingles ever lol. Additional supportive information: The patient received 3 doses of Shingles vaccine, wghich led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a nurse practitioner regarding multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored dose if PNEUMOVAX23 lot K020215, expiry date 15-MAY-2016 (dose number, route, anatomical location and dose units were not specified), (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
My period was 2 weeks early. It was not as painful and didn't have my normal pms symptoms. Flow was like my regular days of my cycle days 3&4, but it lasted 5 solid days. I did not get my period when I was actually due. I know that I didn't have any issues before hand because l just had gotten my results back from my gyn appointment the Friday before and everything was great.
Low grade fever; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and FATIGUE (Felt tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), ROPINIROLE HYDROCHLORIDE (REQUIP), MULTIVITAMIN [VITAMINS NOS], APPLE CIDER VINEGAR, ASTAXANTHIN, GINKGO BILOBA and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Felt tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (Low grade fever) and FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-072933, MOD-2021-378657 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received contains physician details and past procedure and patient demographic updated.
Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021; No adverse event; patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      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 EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021).    Concomitant drugs were not reported. It was reported that the monovalent vial of size 5.5 ml was initially stored in refrigerator on 12-Nov-2021  The vial did not underwent any temperature excursion. Treatment medications were not provided.
1/22pm: Sore throat, muscle aches, chills, temperature 102 F, nausea and vomiting, diarrhea, fatigue, couldn't focus at work.  1/28: Was seen in the Emergency room and treated with amoxicillin
Information has been received from a registered nurse concerning an 18 day old female who on 10/17/1994 was vaccinated with the first dose of hep b vaccine recombinant. Post vaccination, on 10/17/1994, the pt developed a large swollen area at injection site and had hives. The RN stated that the child's reaction was from thimerosal and the child will be revaccinated with thimerosal free vaccine. The pt sought unspecified medical attention. No further info is available.
Client advised staff that he was feeling faint.  Client was given cold water and was seen by EMT.  Client was red/flushed and seemed dizzy.  Client also advised that he was very anxious and worried.  Client seem to staff to be very agitated.  Nurse suggested deep breathing to calm client.  Client was kept in observation for another 10 min.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: rebound infection. tested negative daily for 3 days; Posittive, notes: then felt congested again, tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received dose 5 on Nov2022 at 02:00 PM. Patient received Paxlovid from 01Feb2023 to 06Feb2023 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Child was given DTaP, IPV, and MMR vaccines at  10:10 AM.  She did well at time of vaccines- barely cried, got up from exam table and went to check out with mom and siblings.  Before leaving office child c/o being thirsty and said her throat was hurting.  Mom told staff that she had not been c/o throat hurting before shots but that child was a "drama queen" and child went to water fountain to get water. Mom and child left office at approximately 10:18 AM.  Mom carried child back into office at approximately 10:22 AM.  Child was extremely pale and lethargic.  Dr. was immediately notified and went in to see child.  BP was 66/40 and child was c/o stomachache.  Oxygen was started at 2L per min and 0.2 ml of Epinephrine (1:1000) was given at 10:25 AM.  Oxygen level was 96-98% at this time.  Child's color improved while she was crying after Epi was given.  Child's color turned very pale again as soon as child calmed down.  Solumedrol 35 mg was given IM at 10:30 AM.  Dr. and staff monitored child's condition for several minutes after Solumedrol was given. Oxygen level remained 96-98% even though child was removing oxygen mask periodically.  911 was called at Dr's request because child's skin color had only improved slightly after all of the treatments we had administered.  Child was transported to hospital via EMS.
Itching; Redness; Rashes further spreading over both her legs and also both her arms; hives all over; felt warm to touch her lower back only; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 01Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took pneumonia shot and had adverse reactions on it. Patient received her COVID vaccine the first dose of on the 01Feb2021 and after receiving the vaccine about five hours, on unspecified date of feb2021, she noticed itching, redness and that felt warm to touch on her lower back only and day later she noticed it was spreading to her legs and her arms. Patient prescribed with topical steroid cream (Unspecified Medication) and that was not helping. She also tried using hydroxyzine which she tried for one night and she did not notice any improvement, then she noticed her rash further spreading over both her legs and also both her arms and lots of itching/very severe itching. She visited to the physician on 08Feb2021, and the physician observe that, she had hives all over her body and put her on prednisone for five days 40 mg daily for 5 days and also told her to start Claritin 10 mg daily and take Benadryl as needed, after that she thinks she was feeling better she felt about 40 to 50 percent better, the hives has gotten better but she seems to still had periodic itching which was quite severe, and for that she was using steroid cream and which does seem to help. The clinical outcome of the event hives has recovering, the event itching it was not recovered and for other it was unknown.  Follow-up attempts are completed. No further information is expected.
COVID PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via social media through company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 01-JUN-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced COVID (Coronavirus disease) pneumonia, and was hospitalized with it on 27-NOV-21 (number of days unspecified) (suspected clinical vaccination failure). Patient fought a huge battle with COVID.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the COVID pneumonia and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000206657.; Sender's Comments: V0:20211227883-COVID-19 VACCINE AD26.COV2.S-Covid pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211227883-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Influenza quad Pres Free vaccine given. Within 20 minutes of receiving the vaccine there were 3 red streaks up my forearm. My arm felt heavy and cold the blood vessels felt tingly. This last 1.5 hours.
Systemic: Abdominal Pain-Severe, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe
2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense of taste
No adverse event; First dose was Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (First dose was Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (First dose was Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (First dose was Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (First dose was Bivalent booster).    Concomitant medication information was not provided by the reporter.  Patient came in to get the COVID booster. Patient did not bring the COVID card, so patient was given a Bivalent vaccine, but then the patient revealed that never received a COVID shot.  Treatment information was not provided by the reporter.
Moderna vaccine that was expired on 7/12/22 11:00pm was administered to the patient on 7/13/22 around 2:00pm (1st booster vaccine Moderna 0.25 mL), with currently no adverse effect reported
Patient became dizzy and dry mouth about 10 minutes post injection. Has a bee sting allergy and was afraid she may go into anaphylaxis. Symptoms subsided after about 20 minutes
VACCINE GIVEN @ 511PM, AT512PM, PATIENT STATED THAT SHE FELT DIZZY AND THEN SLID OUT OF CHAIR. MOTHER REPORTED THAT THE CHILD'S EYES ROLLED UP. CHILD REGAINED CONSCIOUSNESS AND WAS RESPONSIVE IN LESS THAN 15 SECONDS. SHE PREFERRED TO SIT IN A CHAIR AFTERWARDS AND WE HAD HER REMOVE HER FACE MASK. SHE LOOKED PALE AND STATED THAT SHE HADN'T EATEN BREAKFAST SO SHE WAS GIVEN A SMALL SNACK BUT THREW UP. SHE WAS ALSO GIVEN COLD WATER TO SIP WHICH SHE KEPT DOWN. A FAN WAS ALSO BROUGHT IN. SHE WAS FEELING MUCH BETTER AT THE END OF THE 15 MIN WAITING PERIOD AND WAS ABLE TO LEAVE ON HER OWN.
About 9 days after vaccination developed  3" diameter red, warm, sore spot at injection site
3x3.75 inches erythematous area on left arm, Mildly elevated. Still present 72 hours after vaccination.
weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0183), via an unspecified route of administration in left arm on 20May2021 at 00:45 (at the age of 52-years-old) at 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. He has no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included sertraline hydrochloride (SERTRALINE). He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at an urgent care center. On 21May2021, the patient experienced slight arm pain for the first 2 days after the shot. On 23May2021, 3 days after the shot, he experienced weakness, fatigue, body aches, headache, sore throat, chills, and slight fever. On May2021, 4 to 5 days after the shot, cough and sore throat became more severe. He still had some fever, but it was reduced by ibuprofen. On 25May2021, 5 days after the shot, he still has cough like he has a chest cold. He also reported that all symptoms started to decrease. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measure was taken as a result of fever and included treatment with ibuprofen. He did not receive any treatment for all other events. The outcome of the event "slight arm pain" was recovered on 23May2021 and recovering for all other events.
I began to feel short of breath, heart palpitations dizzy and weak, had to take medication early and it helped resolve the issues. Made an appointment with cardiologist. I take my medication daily around nighttime; however, it comes and goes once a week where the same symptoms come back. I also experience high heart rates sometimes during the evening.
whole body pain; dizziness; arm soreness; ringing in ears got worse (10/10); sharp pain in stomach; joint pain; chills like flu coming; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)) and ABDOMINAL PAIN UPPER (sharp pain in stomach) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A or 007821A and 022M204 or 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE, SEMAGLUTIDE (OZEMPIC), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION HYDROCHLORIDE (WELLBUTRIN), METFORMIN, MULTIVITAMIN [VITAMINS NOS], ZINC and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)), ABDOMINAL PAIN UPPER (sharp pain in stomach), ARTHRALGIA (joint pain), CHILLS (chills like flu coming), FATIGUE (tired) and HEADACHE (headache). At the time of the report, PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)), ABDOMINAL PAIN UPPER (sharp pain in stomach), ARTHRALGIA (joint pain), CHILLS (chills like flu coming), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-072518 (Patient Link).
Patient received flu and GARDASIL vaccine roughly 4:25 pm. While listening to heart murmur, patient's head lowered, passed out and was lowered to exam table. Lost color in face, brief rigidity to limbs, eyes rolled back, < 5 secs. came to, sat up A and O x3, said he had a dream. Monitored for next 30 min. given 3 glasses of juice. O2 Sat 100%, HR 75. Pt recovered after laying and sitting for some time. Felt fine and walked out of office. Dizziness resolved.
This spontaneous report as received from a medical assistant refers to a 19 month old Child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.