chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15 minutes of patient receiving the vaccine,  patient came up to the counter and told me that he was experiencing a tingling sensation all over his body. I told them to wait another 30 minutes to see if the symptoms would  improve. After 10 minutes, I went to check on him and he said the tingling sensation was gone, but not he was experiencing headache/head pressure  and warm sensation. I told him to continue to wait, which he did and after 20 minutes he said he was feeling  a little better and he was going to head home and rest. I counseled him to continue monitor the symptoms and if they progressed or worsen or if he experienced any new symptoms to seek medical care at emergency room or his primary care doctor depending upon the severity of the symptoms.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration: 06-Aug-2021 No concomitant medications reported. No treatment reported.
Initial misuse report received from a healthcare professional on 30 December 2013. A '65-year-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE INTRADERMAL on an unspecified date, and no adverse event was reported. I.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Patient developed pain and his perception of swelling in (L) axilla hours after receiving injection, which had persisted.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Additional Details: administered vaccine at 2:56 pm. within 5 minutes patient had loss of color, sweating and felt dizzy.  Patient laid on the bench and was responsive the entire time.  Called EMS at mother's request.  Patient walked out of the store with mom and EMS and seemed fine.  Spoke with father about 20 minutes after patient left and he said he was ok.  He said he will follow up with us if anything changes.
Pt received her first FLUMIST 12/11/08. Within 5 minutes she had a dull headache and photophobia. Within 10 minutes she was nauseated and vomited X 1 and her headache was much worse. She then began to feel chest pressure. She denied SOB palpitations, or urticaria. Pt states she was seen by a corpsman at clinic 4 and was given PHENERGAN IM. After a short period of time the nausea, vomiting and chest pressure resolved and the pt was released home and SIQ'd for 48 hours. The headache steadily improved and resolved completely within 48 hours. PMH: eczema which was flared at the time of this incident; no hx of prior adverse events following vaccination; no hx of chronic headaches.
RASH THAT IS WARM TO THE TOUCH, LUMP AT INJECTION SITE. PATIENT STATES THE AREA IS PAINFUL. PATIENT IS SEEING DR 10/29/15 FOR UNRELATED REASON AND WILL INQUIRE CONCERNING INJECTION SITE.
Patient recieved his first dose of Moderna (Covid-19) and as he was sitting in the post vaccination area he fainted, He stated that he normally gets light headed after getting vaccines and he worked 3rd shift last night and hadnt had any food today.
02/25/2021 Vaccination. Didn't feel well for about 24 hours. 03/04/2021 Noticed pain in both shins, skin really red, hot to the touch and very very painful. Hurt to walk, excruciatingly painful. Low-grade fever; 99. Symptoms lasted for a couple of weeks. I saw Dr. and she diagnosed with Anthemia Nodosum, inflammation under the skin fat cells. She prescribed a weeks worth of prednisone and that helped take the swelling down. It took a few more weeks for the symptoms to go away. 03/12/2021 I did take a picture of my feet during this time.
R shoulder 25.8 cm, L shoulder 21.6 cm, R bicep 22 cm, L bicep 18 cm, R elbow 19 cm, L elbow 17 cm.  Redness, swelling noted 9/25 by parents.
lower back pain after exercise; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain after exercise) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no reported medical history).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced BACK PAIN (lower back pain after exercise). At the time of the report, BACK PAIN (lower back pain after exercise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Consumer declined further follow up.
VASOVAGAL RESPONSE  PATIENT PASSED OUT  HIT CHIN ON FLOOR - 4 STITCHES  PATIENT SAT AFTER INJECTION, STOOD UP, SPOKE TO PARENTS, THEN COLLAPSED
This was my 3rd covid-19 vaccination (booster-Moderna) also causing an adverse reaction for about 32 hours. I also had an adverse reaction to my 2nd covid-19 vaccination (first two by Phizer). With both of these, I felt miserable, with painful muscle throbbing and aches especially in my legs causing inability to sleep, chills and sweats, nausea, with head pain leading in to migraine. I had a sore arm at the injection site for both, but with the second vaccination by Phizer, it was very painful and a large lump grew in my armpit of that same arm.
In December 2010 he got three separate vaccinations (Td booster, Flu, Meningococcal) at exactly the same time. Soon his academic performance began to decline in January 2011. By March 2011 I noticed a significant change in his mood as he looked increasingly more depressed and losing motivation is his regular activities. By April 2011 he had his first "psychotic" episode and was diagnosed as Psychosis NOS after being admitted to Behavioral Health. And NOT autistic. He has continued to regress and today he is diagnosed as autistic also.
3/22/21 1015 AM PATIENT RECIEVED THE MODERNA COVID 19 VACCINE at 10:15 AM BY RN IN THE LEFT DELTOID. AT 10:18 AM THE PATIENT BECAME ITCHY, & HIVE WERE NOTED ON BOTH UPPER ARMS BENADRYL 50mg IM WAS GIVEN at 1019AM IN THE RIGHT DELTOID. 10:22am EMS WAS CALLED. BP 121/78, P 95, P. OX 99%. LUNGS CLEAR THROAT PATENT. THE PATIENT C/O RELIEF OF ITCHING, HOWEVER THE HIVES WERE STILL PRESENT. 1039 AM EMS ARRIVED & TOOK THE PATIENT TO HOSPITAL. HX HYPERTENSION, MEDS LOSARTAN 10mg PO NO KNOW ALERGIES - THE PATIENT STATED SHE HAD A SIMILAR REACTION AFTER EATING PIAZZA ON SATURDAY.
Patient complained of redness and itchiness on her left arm where she got the vaccine. The symptom onset was 9/27/2022. The redness expanded from her upper arm to lower arm, but the redness has gone down. She has been self treating at home to relieve itchiness, but has not informed her doctor yet. No signs of infection. Looked like an allergic reaction. Have informed the patient to contact the doctor.
This spontaneous report as received from a currently 73 year old female patient. The patient had no pertinent medical history nor drug reactions or allergies. On an unknown date the patient was vaccinated with ZOSTAVAX vial (route, dose no, dosage and lot number unknown). Concomitant therapies included LIPITOR. On an unknown date the patient developed blisters on her ankle and was diagnosed with shingles after ZOSTAVAX. The patient sought medical attention, (saw the doctor) but had no lab diagnostic studies performed. The patient was reported as recovering from the event. Additional information has been requested.
Sore arm; Mild fever; Fatigue; This is a spontaneous report from a contactable other healthcare professional. An unspecified aged non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 13May2021 at 14:30, as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had history of known allergies to petroleum-based dye. Concomitant medications included ibuprofen (ADVIL) for 2 to 3 times from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14May2021 at 08:00, the patient experienced sore arm, mild fever and fatigue. No therapeutic measures were taken as a result of the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of pain in arm, fever and fatigue were not recovered.   No follow-up attempts are needed. No further information is expected.
Received a full dose 2nd booster by mistake/Received 0.5ML from Red cap vial for 2nd booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full dose 2nd booster by mistake/Received 0.5ML from Red cap vial for 2nd booster) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 012M20A, 031L20A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received a full dose 2nd booster by mistake/Received 0.5ML from Red cap vial for 2nd booster). At the time of the report, ACCIDENTAL OVERDOSE (Received a full dose 2nd booster by mistake/Received 0.5ML from Red cap vial for 2nd booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant and treatment medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and the agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat at Injection Site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat at Injection Site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (Heat at Injection Site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
she now has fever reaching 104; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 27Jan2022 (Lot number: FL0007) at the age of 10 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "she now has fever reaching 104". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: on an unknown date inJan2022, the patient's fever was 104.  No follow-up attempts are possible. No further information is expected.
Shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. In 2013, plaintiff was inoculated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) as prescribed and/or administered by a pharmacist for the long term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequently to Plaintiff's zoster vaccine live (ZOSTAVAX) inoculation, plaintiff was treated at a medical office for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX), Plaintiff had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not provided.  The lawyer considered shingles to be related to  zoster vaccine live (ZOSTAVAX).
A soon the vaccine was giving High fevers start occurring with the chills went to the hospital because 10 days we high fevers and chills has gone bye the hospital diagnose was that the immune system  was down And the blood count specially white cells were really low and infections like liver was occurring
flu; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non- healthcare professional via social media.  This case is linked to case 2020SA290167(same reporter).  This case involves patient (age and gender unspecified) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu (influenza), (unknown latency, non-serious event).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
tingling all over and on her face; This case was reported by a consumer via other manufacturer and described the occurrence of tingling in a 80-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included thyroid disorder, glaucoma and drug allergy (gets rashes from certain medications like Macrobid and gets severe diarrhea from certain antibiotics like Ampicillin, contrast dye if taken orally). Additional patient notes included Ethnicity. Concomitant products included levothyroxine sodium (Synthroid) and vitamins nos (Vitamin Supplement).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tingling. On an unknown date, the outcome of the tingling was recovered/resolved.   It was unknown if the reporter considered the tingling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient had allergy from certain medications like Macrobid and got rashes and got severe diarrhea from certain antibiotics like Ampicillin, contrast dye if taken orally and hence had to take it by intravenous route. Concomitant medications included Synthroid, Lumigen drops one drop each daily for glaucoma, and other vitamins and supplements that she had been on for 10 years. The patient was very healthy, she walked and did not have any issues with her. The patient had received the Flu vaccine in 2018 and experienced tingling like the same thing that happened with this vaccine.  She did not had a manufacturer, lot or expiration for it.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # reported as M011840, expiration date 01-FEB-2018, lot # M030380, expiration date 01-FEB-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 58 degrees Fahrenheit for 3 hours. Data logger was involved. There was previous excursion of 63 degrees Fahrenheit for 2.5 hours reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014982: US-009507513-1704USA015043: US-009507513-1704USA015044:
Left deltoid pain at site of injection. Pain 7/10. Inability to sleep. Inability to abduct arm greater than 40 degrees. Pain remainded 7/10 x 72 hours.
Initial unsolicited report received from a consumer on 30 September 2015. Addendum 26-Oct-2015, upon second medical examination another event Multiple sclerosis had to be coded, which makes the case serious and processed accordingly. This case involves a female patient (age not reported) who was vaccinated with a dose of flu shot (batch number, dose, route and site of administration was not reported) on an unspecified date. Patient's medical history included multiple sclerosis. The patient was taking AUBAGIO (dose: 7mg x 1 mo then 14mg via oral route four times a day) concomitantly for multiple sclerosis. On an unspecified date, following the vaccination, the patient had a relapse of existing condition. Presently the patient reported that she was not able to drive. Lab data and corrective treatments were not reported. The outcome of event was unknown. List of documents held by sender: none.
Left shoulder pain after flu shot. No pain at time of injection at all.  Significant continuous pain began within 1 hour of injection. Pain is now mostly felt when reaching or lifting certain ways and is more intermittent in nature.  Have taken NSAIDs with variable results as treatment.
Macular Papular rash.  Started with one papule on left hand, then one on left side of face during the month of March 2021. These resolved on their own.  Then noticed the evening of April 24th a dime size maculopapular rash on side of left foot.  Hoping this resolves on its own. I have an appointment with my dermatologist in July.
02/20/2021, aches, chills, fever, weakness in legs, all COVID type symptoms, lasted 10 days.
Okay I have been having joint aches, especially in my knees. The big problem I got is that my legs swell up, I have never had that happen before. I also experience lower back pain. This began maybe 3-4 weeks after the vaccine, and I did not relate it to the vaccine although it is unknown. I contacted my DR about a month post vaccination. My DR tried treating me, I also get pretty bad cramping for my hands. She got me on a medication to relax muscles - cyclobenzaprine 10MG 3x a day. DR also gave me meloxicam 15MG 1x daily. I also see a vascular DR this Friday, July 9th 2021, about the swelling in my legs.
Nausea; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (chills) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), CHILLS (chills) and PYREXIA (fever). At the time of the report, NAUSEA (Nausea), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications were reported.
Red, swollen, and itchy arm. The area of injection is also more firm than the rest of her arm. Erythema at site of injection. Delayed reaction.