chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Note, because of some acid indigestion I took a Walzan-75 prior to bed time 11 PM 12/12/2015. At 1:00AM or 2:00AM itchiness noted near site of vaccine. Scratched it. In the morning took a look and there was a red patch next to the bandaid 3 inches long, 2 inches wide. Still a little itch at time of writing this. Same amount of redness.
Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023; Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023).    No concomitant medications were reported. It was reported that Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023. They were to be used within 24 hours but administered to 24 patients on unknown dates. Vaccine administration dates and patient information were unknown.  Excursion Timeframe, on 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023 Max 8.5 C for 24 hours, on 23-Feb-2023 Max 8.5 C min 7.4 C for 17 hours and 56 minutes. No treatment information was provided by the reporter. This case pertains to patient 8 th out of 24 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-713467, US-MODERNATX, INC.-MOD-2023-713484, US-MODERNATX, INC.-MOD-2023-713485, US-MODERNATX, INC.-MOD-2023-713504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713467:Patient 1 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713504:Same Reporter US-MODERNATX, INC.-MOD-2023-713484:Same Reporter US-MODERNATX, INC.-MOD-2023-713485:Same Reporter
Sagging left lip; rash under arms; This is a spontaneous report from a contactable other hcp (patient).  A 68-years-old male patient received bnt162b2 (BNT162B2, brand: Pfizer) first dose, via an unspecified route of administration at arm left on 20Jan2021 10:30 AM at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient had no allergies to medications, food, or other products. Concomitant medication included atorvastatin, vitamin d3, alpha lipoic acid received within 2 weeks of vaccination.  The patient experienced sagging left lip on an unspecified date with outcome of unknown, rash under arms on an unspecified date with outcome of unknown. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect vaccine BNT162B2 to the event facial droop cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
My period started the day after I received my first shot. I was only on day 8 of my cycle, which is extremely regular and usually 26 days in length.  The period was 5 days to my typical 3 days.
4 hrs post receiving influenza vaccine pt experienced hot & cold, nausea, vomiting and LOC ? duration.
Pt recv vax on 3/17/99; 4 1/2 hr post vax pt exp grand mal seizure, lost control of bodily functions, "out of it"; pt taken via ambulance to hosp
I became very dizzy. My heart rate was very fast. My blood pressure was 157/82. My normal blood pressure is 120/70 I had chills, and tired
HPV vaccination should have been given. Prevnar 13, was given instead. No adverse effects noted in patient, per patient
SM describes a large local reaction following his 4th and 5th anthrax shots. Both shots given SQ. Developed pain and swelling at injection site within 24 hrs. Resolved after 3 days with use of cold packs. No residual symptoms. Did not affect work or PT.
The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023; No adverse event; Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023).    Concomitant drugs were not reported. It was reported that it was patient's fifth Moderna vaccine. It was also reported that the bivalent individual vials stored in carton was of 2.5 ml size. The vial was initially stored in the refrigerator on 29-dec-2022. The vial did not underwent any temperature excursion.
had an allergic reaction to the second dose; This spontaneous report was received from a patient's mother and refers to a male patient of an unknown age. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug allergies and reactions was provided.  On an unknown date, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, frequency, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was vaccinated with a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, frequency, lot # and expiration date were not provided) for prophylaxis.  On an unknown date, the patient had an allergic reaction to the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  The outcome of the event was unknown.  Causality assessment between the event and the suspect therapy was reported as related.
Information has been received from a physician concerning a 7 year old patient who was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (No lot number was provided). On approximately 27-JUL-2007, the patient developed injection site redness and injection site swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Dad reported sx-like jerking of upper torso appr 15 mins> immun; poss apnea for a few secs; cyanosis of lips & nailbeds & lethargy x 15 mins; skin cool & clammy & pale; seen @ ER; multiple test run - all WNL x/inc Calcium; PT d/c in 1.5 hr;
Dark red circle, raised small bumps, warm to the touch. started getting smaller and lighter day 5.
Pt. reported to PHN that she developed chest pain and SOB on exertions on 5/6/2023 in morning.  Pt. reports she has had 2 episodes of partial lobal lung collapse in rt lung "many years ago".She is a retired doctor/radiation oncologist, and felt the symptoms were not cardiac in origin.  She waited until Monday morning and didn't feel better, so she went to her regular NP and cbc, complete metabolic panel and x-ray was taken. Infiltrate in lingula seen. She was dx with pneumonia and prescribed  augmentin x 7 days and erythromycin x  5 days. She told NP that she had had the Moderna vaccine the day before sx start and asked if she could have gotten pneumonia from it. The NP said they were not certain if the vaccine caused the pneumonia or not. Pt. states the pneumonia symptoms resolved after 1 week, but still feels fatigued.  Pt. reports she feels 90% recovered after 1 week. PHN advised this should  be reported to VAERSand pt asked for PHN assistance in reporting.
I was fine up until I went to my dental appt and had my BP taken. The bottom number was 98 and my pulse rate was over 100 (which is not normal for me), so I scheduled an appointment with my PCP to get checked out. My PCP performed a physical and did bloodwork. He added Bystolic to my regimen and it has helped to regulate my BP.
Flu like s/sx 3-4 days after vaccine that resolved. Later on pt developed s/sx consistent with transverse myelitis.
Rec'd Flu Vac yesterday. Pt states injection site became sore and red approx 4-5 hrs after inj. This am entire (R) deltoid and below was red and warm. Pt alert and swelled up approx 1100 today. Approx 1330 today mom called, pt vomiting. Told, to go to hosp.
pt recv vax & pt devel hepatitis B, which was dx p/a visit to MD;the reporter felt that the hep B was r/t vax;
This is a spontaneous report from a contactable other hcp (patient). A 48-year-old female patient at same age receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 13:15 on right arm at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced extreme fatigue for a few days on 23Jan2021. The outcome of event was recovered. She is not pregnant. There was no treatment AE, no covid prior vaccination and no covid tested post vaccination. Information about Batch/Lot number has been requested.
9/10/10 fever, mild to moderate headaches, at times severe, nausea, vomiting, poor appetite, ache in neck, joints and muscles, weak and mild dehydration. Admitted to hospital 9/23/10 with persistent symptoms.
Sudden, severe croup coughing with elevated body temperature (2 degrees above normal 97 F for her).
Parents concerned that child has had an abnormal weight gain since receiving GARDASIL vaccine - BMI - BMI 2 months before 1st GARDASIL was 2 cm.  BMI - tests - 1 year after 2nd GARDASIL is 3 cm.  Child's nomstrad cholealyagy very regular - child had diarrhea for 3 months after 2nd GARDASIL - mother to give Benadryl.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that on an unknown date multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (dosing details were not reported) (therapy type: Digital Data Logger) (lot # L044917 with an expiry date of 05-OCT-2018), at a temperature of 51 F for a time frame of 5 years (Incorrect product storage). There was a previous temperature excursion reported for RECOMBIVAX HB at a temperature of 59 F for 29 hours. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Patient had been having some unusual medical symptoms, personally, that she had never experienced before. They started last week. Namely, tremendous pain and discomfort in hips and shoulders. It very much mimics polymyalgia rheumatica. The only change in her life within the last three weeks was that I received the Covid vaccine.
big, hot red angry painful and itchy oval blotch.  lasted a week and spread for a week.  started small and got big.  i also received the shot in the BACK of my arm where there is fat, instead of right below my shoulder on the side of my arm where most shots are usually given .
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-AUG-2016, reported as yesterday, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (lot# reported as M024698, expiry date 27-JUN-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporter stated that the dose of ZOSTAVAX was exposed to a temperature excursion of 39 degrees Fahrenheit for a time frame of 14 hours. There was no previous temperature excursion involved. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age with drug reactions and allergies to BENADRYL, Comprasene and Toprex reporting on herself. No pertinent medical history was reported. On 22-JUL-2013 the patient was vaccinated with PNEUMOVAX 23 (lot#, dose and route unspecified). Concomitant therapy included Hydrochlorazide. On an unknown date, the patient experienced that her whole arm was sore and painful with swelling and was useless for 3 days. No treatment was given for the events. At the time of the report the outcome of the whole arm was sore and painful with swelling was unknown and the outcome of whole arm was useless for 3 days was reported as recovered. Additional information has been requested.
Arm and vaccination site not sore until this morning, but tolerable. Felt very sleepy starting at around 5:30pm yesterday. Had a good night sleep but very tired and sleepy this morning. Low energy.
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: PATIENT PASSED OUT AFTER ABOUT 5-10 MINUTES OF THE VACCINE, HISTORY OF FAINTING. MAY HAVE BEEN DEHYDRATED DUE TO YARD WORK. FEAR OF NEEDLES AS PER PATIENT. PATIENT CAME BACK BY HIMSELF, CALLED 911 FIRE DEPT MONITORED BP AND DID CHECKS BEFORE LETTING HIM GO. PATIENT REFUSED TO GO TO THE HOSPITAL AND WALKED OUT WITHOUT HELP.
Can't sleep; Bowel issues; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Mar2021 at 14:00  (at the age of 64-year-old)  and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, high blood and osteoarthritis. The patient's history of known allergies was reported as none. The patient has taken unspecified concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, the patient experienced insomnia and  bowel issues. The patient did not receive any treatment for the reported events. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events insomnia and bowel issues were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1/24/11: inj given (L) arm 1/25/11: inj site redness and sl.swollen, itching, tried BENADRYL & ice packs. 1/28/11: in office started on Prednisone 20 mg 1 tab x 7 days.
The same day I got the shot, I started my period. I wasn't due to start for another 2 weeks, and my period is like clockwork. I spotted for a few days, stopped, then skipped a month. Then I started July 25th, and have not stopped bleeding since. Normal to heavy bleeding, for now 106 days strait.
Strong muscle ache and tiredness.  ~48 hours.  Ibuprofen after about 24 hours, one dose.
The local and immediate symptoms were routine.  The long-lasting, and ongoing, symptoms are the concern.  Symptoms developed gradually and on 9/21/21 were reported to Dr.  Symptoms included bilateral hip and shoulder stiffness and aching, and sometimes lower back, with whole body malaise.    Heart palpitations became prominent for a few weeks in September.  The second Shingrix dose was on 10/21/21 and the overall condition became precipitously worse.  Although diagnostics for the pain and malaise led to nothing specific, prednisone was started on 1/1/22, with immediate and complete symptomatic resolution by 1/5/22.   A working diagnosis of polymyalgia rheumatica was made by exclusion.  Typical approaches to tapering the prednisone have had limited success and currently no prednisone is being taken but the symptoms are mostly returned.  The diagnosis of polymyalgia rheumatica fits mostly but more accurately, this is a post-vaccination autoimmune rheumatic syndrome.
Patient was post receiving  Moderna Covid19 vaccine and was in observation area AT 3:00 PM  Felt lightheaded and reported to assistant in area.  Patient was taken to cot.  Blood pressure, pulse  and pulse oxygen, results were within normal parameters.  She reported not having had much water during day, only sips. Rested for 20-30 minutes and reported feeling better and she left and drove herself home.
Diarrhea; Fever; Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03922) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Diarrhea, at an unspecified dose and frequency. On 17-Apr-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.
Vaccination adverse reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            No concomitant medication were provided. No treatment medication were provided.   Reporter did not allow further contact
A rash as itchy as poison ivy across both upper legs, under both armpits all the way to fingertips on both hands, on chest and spreading so fast I could actually SEE more forming while I took a shower. I made a mistake on the time of day that I got the 2nd shot, it was at 9:20 a.m. not 8:30. I knew it was earlier in the morning.
Information has been received from a physician concerning a 11 year old female who on approximately 27-JUL-2009 (also reported as "4 to 5 weeks ago"), was vaccinated with a first dose of GARDASIL (lot  number not reported). 2 weeks after the vaccination, the patient had hair loss. The patient contacted the physician via phone. At the time of the report, the patient's status was unknown. Follow up information was received from the physician concerning a 13 year old (not 11 as previously reported) female with no illness or other medical conditions who on 14-JUL-2009 at 17:00 was vaccinated into the left arm with the first dose of GARDASIL (lot# 659655/1486U). Approximately 4 weeks post the vaccination, on 20-AUG-2009 the patient experienced increased hair loss which lasted about 2 month. There were no laboratory diagnostic studies performed. Two months later, on approximately 04-OCT-2009, the patient recovered from hair loss. Additional information is not expected.
Chills, fever of 101 degrees, severe headache and body aches. Took Tylenol every six hours over the course of four days.  Due to my Meniere's disease, these symptoms also exacerbated balance issues for seven days total.
Fatigue, chills, shivering starting 15 hours post vaccination Significant pain around injection site (clothing brushing on injection site causes sharp pain) Redness and swelling around injection site Redness and swelling extending 2 inches in one direction from injection site