chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mom reports pt had very light, fine rash on chest, arms, feet & face;rash was not raised;mom noticed this rash 830AM the morning p/vax given;rash lasted 1 day;mom gave 1 dose of DPH per MD;
possible 3rd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (possible 3rd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETAMINOPHEN and IBUPROFEN for an unknown indication.    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 EXTRA DOSE ADMINISTERED (possible 3rd dose). At the time of the report, EXTRA DOSE ADMINISTERED (possible 3rd dose) had resolved.            Patient has taken 3rd dose No concomitant medications were reported. No treatment information was provided.
Pt reported dizziness and the sensation of the room spinning.  Pt given juice, crackers and lay supine.  Pt reported that she had similar reaction w/ 2nd dose.  Pt denies pain, nausea, itching, SOB, no Hx of DM.  AxO x3 skin dry, warm, no rash Vitals: 18:07 110/74, 96, 18, 100% -- > 1824 113/77, 92, 18, 100% -- > 18:35 120/76, 89, 18, 100% -- > 18:40 124/89, 93, 18 No meds needed/given, not determined to be a vasovagal rxn Pt stable and released from the vaccinatin site 18:47
Swelling to the sight of the injection, "to the size of a softball." Swelling noted soon after administration. Reports utilizing ice to area. Also utilized Claritin, Zertec, and Tylenol. "Some" decrease in size with interventions. Has not seen a provider, encouraged to contact.
Clotting issue; My legs are covered in bruises; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 21Apr2021 10:15 (at the age of 35-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included known allergies: Tree nuts from an unknown date and unknown if ongoing. Concomitant medication(s) included clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for allergies, start and stop date were not reported (other medications the patient received within 2 weeks of vaccination). The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reported that It was now the 23rd and I took my pants off at the end of the day and my legs are covered in bruises (22Apr2021). There was inadequate data online pertaining to this reaction and I was concerned it was due to the clotting issue (22Apr2021). There was no treatment for the events. The clinical outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Numbness left side of body within one hour after first dose on August 27th. Lightheaded and dizziness started about four days after first dose and lasted for about two weeks.
Information has been received from a physician referring to 4 patients of unknown age and gender. Information about patients' concomitant medication, concurrent condition and medical history was not reported. The physician reported that on unspecified dates ranging from 17-FEB-2016 through 22-FEB-2016, the patients received doses of improperly stored LIQUID PEDVAXHIB (dose and route not reported, lot # J016186 with expiration date 24-OCT-2016), according to a report of data of 30F for 15 minutes on 17-FEB-2016". The physician also stated that her refrigerator was in correct range and the VFC data was wrong due to the "incorrect placement of a probe". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
an extremely itchy, red, sore, slightly swollen patch on my upper left arm (but not the exact site of the injection) about 2" x 1". So far, symptoms have subsided after 22 hours  except for redness.
At 1 am on 11-3-11 pt was cold & had chills in chest, arms & hands all night long & could not sleep. At 6am on 11-3-11 pt felt hot & had pain in neck, head, & jaw & was dizzy with headache. On 11-4-11 pt rested all day & feeling better. Pt called us at 9:20 pm on 11-4-11 to tell us her experience.
Headache - 8:00pm 1 1/2 hrs after injection lasting until current time (50 hours later)   Chills, sweating -  7:00am to 7:00am the day after injection  Fever, pain - 3:00pm to 12:00am the day after injection  Loss of appetite - 7:00am to 12:00am midnight day after injection  Fatigue - 7:00am to 12:00am midnight day after injection (still slight fatigue currently at 50 hrs after injection)
Patient DOB:  came to vaccination site on 2/20/22 to receive her Pfizer COVID vaccine booster dose. Patient received Moderna Booster COVID vaccine instead. RN was notified of the medication error. stated to RN, "We just vaccinated a 15 year old with Moderna"., RN went to go check on patient in observation area. RN spoke to patient's mother ,and explained medication administration error. RN educated patient and patient's mother on adverse reactions of Moderna COVID vaccine and when to seek EMS. Patient and patient's mother verbalized understanding. RN gave patient's mother Modern COVID vaccine fact sheet. RN. RN stated that patient's mother gave him a laminated purple Pfizer card that is used at check in to identify which vaccine patient is receiving. RN stated that patient was seated at his table by RN. RN stated that he asked patient if she was receiving a Moderna COVID vaccine booster and she replied, "yes". RN confirmed that he seated the patient and their mom at RN 's vaccination table. RN stated that RN's vaccination table sign read Pfizer. RN and RN spoke to stated that when she opened the patient's vaccine record on  she saw the patient was scheduled under Pfizer booster. tried changing the appointment to Moderna but the system did not allow her to do so. RN asked why she was not able to change the appointment. RN stated that the patient was 15 years old stated, "that by then it was too late because RN had already vaccinated the patient". Patient completed 15 minutes of observation. Patient did not report any adverse reactions. Patient left vaccination site with her mom unassisted and with a steady gait at 1640.
Administration of a third dose of an mRNA vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Administration of a third dose of an mRNA vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Administration of a third dose of an mRNA vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Administration of a third dose of an mRNA vaccine) outcome was unknown. Not Provided      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.   No concomitant medications were not provided. No treatment medications were not provided.
pt recv vax 16APR96 & devel an inj site rxn, characterized by a knot & redness, measuring 10cm x 8cm;pt was treated symptomatically, & recovered in 9 days;
corroded artery pain into face on left side, sinus drippage, sinus cavities hurting, lump on neck
A spontaneous report was received from a consumer concerning a 30-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced breastfeeding.  The patient's medical history was not reported.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot# 037K20A) intramuscularly for prophylaxis of COVID-19 infection on 29 Dec 2020.  On 30 Dec 2020, the patient was breastfeeding after taking the vaccine.  She reported no symptoms and consented to follow-up with her primary care physician.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter's Comments: This is a case of product exposure for  mRNA-1273 (Lot# 037K20A)  during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs
Rash over bilateral AC, bilateral lower legs, and bulla over bilateral forearms, with erythematous papular rash over neck and chin and abdomen.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-01-20.
10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started ching so bad that the soles of my feet hurt when walking. Temp increased during the night with sweats and cold chills. My usual body temperature is around 97 so when it went to 102.2, that is a high fever for me. Didn't sleep much because of all the discomfort. Nose totally clogged up, had to breath trough mouth only. Temp went down to 100.5 by the mroning. Slept all day and untill 5 AM Sunday 5/16. Very sore and took some Advil Saturday late afternoon. Didn't help. Sunday, now at 5:40pm ET, temp has returned to normal, but I am still sore all over and have no energy.
Patient states that about 10 days after her vaccine she developed a Staph infection on her left arm which is the same arm as her vaccine. She does not know if the vaccine was the cause but wanted to report it to us anyways.
Patient was vaccinated and within 10 minutes bilateral hands started swelling, chest tightness as well. Patient took 100mg benadryl po and within 15 minutes swelling decreased. Speaking with patient at 1654 patient denies any symptoms and hand swelling and chest tightness are completely gone.
Patient became lightheaded, with a head ache and patient stated he was about to faint.  Patient received fluids.  Patient states that symptoms no longer present.
No additional AE or PQC reported; HCP reported MMR II was inadvertently administered with PROQUAD. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 06-FEB-2023, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U017524, expiration date: 03-JUN-2023 (strength, and route of administration were not provided) and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #W017572, expiration date: 29-NOV-2023 (strengths, doses, vaccination schedules, sites and route of administration were not provided) for prophylaxis (Accidental overdose). No additional adverse event was reported.
This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak) and DIARRHOEA (Diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure abnormal since an unknown date.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore injection site for 2-3 days). On 18-Mar-2021, VACCINATION SITE PAIN (Sore injection site for 2-3 days) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used were Blood pressure medication. Treatment information include Paracetamol and Loperamide.
Patient recieved second Moderna COVID vaccine on 02/06/2021 at 0940 at Hospital. Patient reported fever of 100.2 this morning 02/07/2021. patient did not take any medication for symptoms. patient denies any allergies. patient has hypertention. Patient reported he takes Olmesartan 20 mg. I instructed the patient to monitor his fever and to seek medical attention if fever persisted. I instructed the patient to take Tylenol if needed.
Red, swollen, itchy and painful arm with full body aches started around 7 pm; and lasted 30 hours.
received vaccine and immediately had sharp pain down arm and numbness to the fingers. Numbness is gone today 10.4.22 having trouble lifting arm and any ROM of left arm
Patient's left deltoid was red, hot and swollen at injection site which was about 3 cm in diameter. The swelling around the red went out 4-5 cm beyond that in diameter. The area was very itchy. The patient stated that she never had a reaction like this before with TDaP.
Patient presented as nauseous, light headed, and "felt funny". Patient appeared to space out temporarily. Paramedics gave her a full work up and said everything was in normal limits but recommended she see a doctor in the ER to be safe.
Information has been received from a registered nurse referring to an unknown number of unspecified patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unknown dates in 2016 (reported as "unknown dates starting on or after 15-JAN-2016") the patients were administered with improperly stored doses of PNEUMOVAX23 (dose, route, lot # and expiration date not reported). The vaccine was improperly stored at 0 degrees for 90 hours. Data logger was involved. There was no previous excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right axillary lymphadenopathy (still ongoing) with ongoing edema of right axilla, flank and abdomen (ongoing). Seems to be slowly improving.
This case was reported in a literature article and described the occurrence of optic neuritis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 5 days after receiving Meningococcal ACWY-CRM vaccine, the subject developed optic neuritis. Serious criteria included GSK medically significant. The outcome of optic neuritis was unknown. The investigator considered that there was a reasonable possibility that the optic neuritis may have been caused by Meningococcal ACWY-CRM vaccine. Relevant Tests: In this study, the diagnosis (Optic Neuritis) was made by either an ophthalmologist or a neurologist. Additional information was provided. This case was reported in a literature article and described the occurrence of optic neuritis (ON) in a patient of unspecified age and gender who was vaccinated with unspecified meningococcal conjugate vaccine (MCV4) (manufacturer unknown). The patient was a part of the case-centered analysis that aimed to determine whether the observed rate of vaccination before onset of optic neuritis (ON) is higher than expected, by comparing vaccination rates in patients with ON to those in the matched general population during 1 January 2007 through 31 December 2012. The study estimated both the multiplicative effects (relative risk) and the additive effects (risk difference) of ON after vaccines in persons of all ages. The patient had no medical history of multiple sclerosis and ON. The study was conducted at healthcare system. No information on patient's family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified MCV4 (administration site and route unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between 2007 and 2013, between 5 and 28 days (exposure interval) following vaccination, the patient was diagnosed with ON. Treatment was unknown. The outcome of the event was not reported. The author commented "Our study found no evidence that vaccines are associated with development of ON in the 4 or 6 weeks after immunisation". The authors concluded, "We found no increased risk of ON after immunization. We had power to detect a small excess risk, and it is reassuring that we found no evidence of excess risk for ON after any vaccine". This is 1 of the 2 valid cases reported in the same literature article.
Site: Pain at Injection Site-Mild, Systemic: Patient claims to have experienced amnesia (not able to remember date/day/time). Issue resolved after 4-8 hours-Medium
Low fever of 99.9°F starting about 27 hours after vaccination & lasting through the day, chills during the night after vaccination, body aches, fatigue, & headache during the day after vaccination (in general, all common side effects, but I still wanted to report them for statistical purposes), rested & used a cold compress to manage symptoms, recovered by the second day following vaccination
Mother reports red papule, initially on thighs in the injection site, one day after immunizations (9/4/19). In the next day, noticed that rash progressed. Affecting entire thighs, most pronounced in the right. Denies previous episodes.
Short syncopal episode - on table, as laying down, passed out but came to almost immediately. Later in day - vomiting, 100.8 oral fever, headache, achy, fatigue next day. Out of school x 3 days, felt "out of it". Shot given Monday, returned to school Thursday.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Mucus in nose, throat and eyes. Pins and needles paresthesias throughout body. Narrative: 1545. Dizzy & Fever ~ 1800. Woke up in middle of night felt feverish with pins & needles sensation. Couldn't sleep with blanket. Headache, difficulty breathing due to mucus in nose, throat and eye. Nauseated. Diarrhea. Mom took care of her Sun and Mon. Came back to work on Weds. Still has cough, mucus, headache and body aches.
Have the flu; Can barely walk; Sore; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (Have the flu), GAIT DISTURBANCE (Can barely walk) and PAIN (Sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced INFLUENZA (Have the flu), GAIT DISTURBANCE (Can barely walk) and PAIN (Sore). At the time of the report, INFLUENZA (Have the flu), GAIT DISTURBANCE (Can barely walk) and PAIN (Sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-466357 (Patient Link).
About three hours after the vaccine, I began to feel muscles aches all over my body and fatigue started. I took some Tylenol at noon. The vaccine was on a Friday morning. The next two days (Saturday and Sunday) I felt the same, but with more malaise and continued to take Tylenol. Sunday evening I started to feel better, but not great. Monday I felt the same and then Monday evening my lower lip and chin broke out in blisters about the size of a pea. Tuesday morning I awoke with a larger cluster of blisters on the lower lip and chin that has grown to about the size of my thumb. The blisters are tender and painful. I am uncertain if the vaccine was Shingrix or Zostavax.
catching a cold; diarrhea; experienced chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (catching a cold), DIARRHOEA (diarrhea), CHILLS (experienced chills), PYREXIA (fever) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034s21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced NASOPHARYNGITIS (catching a cold), DIARRHOEA (diarrhea), CHILLS (experienced chills), PYREXIA (fever) and NAUSEA (nausea). On 13-Nov-2021, NASOPHARYNGITIS (catching a cold), DIARRHOEA (diarrhea), CHILLS (experienced chills), PYREXIA (fever) and NAUSEA (nausea) had resolved.            No Concomitant medications were provided No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-384941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-384941:Case link to same patient containg dose 1,2 information
Symptoms: Left Shoulder Soreness, pain, weakness, reduced range of motion. Treatment: Tried  unsupervised exercises at home.
2-3 days p/vax pt has sx's of high fevers up to 103-104, no eppetite, listlessness, weakness; was seen by MD-nophysical findings other than sx's; lasted x 1 wk; was observed & fluids encouraged;
pt recv vax 26OCT95 & 14NOV95 pt devel a low grade fever;21NOV95 pt devel less than 15 lesions that pussed & scabbed;no further details were provided;
Information has been received from a nurse and concerning a patient of unknown age and gender. There was no information about patients' concurrent conditions, medical history or concomitant medications. On 14-MAR-2017, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # L033549 and expiration date of 05-JUN-2017, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celsius degrees (11.25 Celsius degrees) for 24 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US--009507513-1801USA006861: US--009507513-1801USA006860.
This applies to both vaccines:  Within less than 12 hours, i had  local injection site soreness, severe muscle weakness and aches in bilat legs, fever, chills, lower back pain,  all-over joint/muscle pain, diarrhea, headache, nausea .  All symptoms lasted approx 24-30 hours.
swelling of arm at sight on injection - no use of left arm - fever over 103 - dizziness - chills and cold sweats - went to be seen at Hospital the evening of 12/11/2010 and was treated with antibiotic for possible infection and vicodin for pain
I started bleeding vaginally and am still bleeding 20 hours later. I have been in full menopause since 2013 after having both of my ovaries removed. And, was diagnosed with breast cancer in October of 2019, surgery in February 2020, followed by 5 weeks of radiation therapy. The type of breast cancer I had was due to hormones, so any hormones in my body could potentially cause a recurrence of the cancer.
Acute Myopericarditis after First Dose of mRNA-1273 SARS-CoV-2 Vaccine  Treatment included lisinopril once daily, colchicine twice daily, and ibuprofen every 8 hours