chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, hot, swollen, itchy circular rash at the site of inject. Appeared a few days after receiving the shot. Treated with ibuprofen and lasted 4 days before disappearing
Spoke with pt by phone at approximately 11 am this morning. Pt states she woke up this morning around 10:00 am and her face was red and swollen. Pt also complains of "feeling hot." Referred to PCP.
after 18 hours: experiencing high fever, pain, dizzy, nausea, vomitting, lose appetite.
p/vax pt exp fever to 100.5 & arthralgia; mild swelling; warm to touch
Patient got up immediately then fainted in the store. Did not report any injury. Told again to sit until stable so we could monitor.
she experienced pain in her arm; Hurting and very hot to touch at injection site; She experienced soreness of upper arm; Itchy at injection site; She experienced a swollen arm at injection site.; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical information was not provided by the Reporter.  Concomitant products included METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), VITAMIN D [VITAMIN D NOS] and ESTRADIOL for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extreme fatigue; Loss smell/Reduction of smell by 50%; Fatigue after his second shot; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss smell/Reduction of smell by 50%), FATIGUE (Extreme fatigue) and FATIGUE (Fatigue after his second shot) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 011M204) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included FLUOXETINE, TESTOSTERONE, ROSUVASTATIN, FLUTICASONE and METFORMIN for an unknown indication.   On 11-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (Fatigue after his second shot). On 13-Mar-2021, the patient experienced ANOSMIA (Loss smell/Reduction of smell by 50%). On 13-Apr-2021 at 9:00 AM, the patient experienced FATIGUE (Extreme fatigue). The patient was treated with METHYLPREDNISOLONE for Fatigue and Loss of smell, at a dose of 4 milligram (Dospak 21s). On 30-Apr-2021, FATIGUE (Extreme fatigue) had resolved with sequelae. At the time of the report, ANOSMIA (Loss smell/Reduction of smell by 50%) had not resolved and FATIGUE (Fatigue after his second shot) outcome was unknown.            Patient had fatigue after his second shot which was gradually increasing.  On 07-Apr-2021, the event was reported as worst (severe fatigue).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Reporter contact details updated, patient demographic details updated, allergy, suspect product's administration time, concomitant drug information, treatment medication, batch/lot no, additional event  extreme fatigue and loss of smell was added.
One Oct. 30, both eyes became irritated and photosensitive. Went to doctor on Nov. 4. He diagnosed inflammation of conjunctiva in both eyes, and redness of the sclera above both irises. Prescribed steroid drops and eye lubricant. No improvement, so went back to doctor on Nov 10. Doctor added antibiotic ointment to the medications. Some improvement by Nov 17 when returned to doctor. Significantly better as of today (Nov 23).
INCORRECT STORAGE OF VACCINE; ADMINISTRATION OF VACCINE WHICH WAS STORED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 47 year old male. 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 not reported, batch number: 1822809, expiry: 04-AUG-2022) dose was not reported, administered on 22-FEB-2022 for prophylactic vaccination.  Age at time of vaccination 47 years old. No concomitant medications were reported.  On 22-FEB-2022, the patient experienced administration of vaccine which was stored outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine which was stored outside of recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558340, 20220558345, 20220558451, 20220558511, 20220558598, 20220558439, 20220558390 and 20220558823.
Shingles within 60 days of the vaccination shot; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8736) via an unspecified route of administration in the right arm on 28Apr2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease. The patient did not have allergies to medications, food, or other products. Concomitant medication included mesalazine (MESALAMINE); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the right arm on 01Apr2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jun2021, the patient experienced shingles within 60 days of the vaccination shot. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were taken as a result of event and included treatment with antiviral tablets valacyclovir (MANUFACTURER UNKNOWN) and unspecified steroid eye drops. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles within 60 days of the vaccination shot was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
administration date: 31Jul2021; This is a spontaneous report from a contactable Nurse (patient reporting herself). This 56-year-old female Nurse (Patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FA7485) via an unspecified route of administration on 31Jul2021 at 11:30 on left arm (at 56-year-old), as dose 2, single for COVID-19 immunization. The medical history of the patient included spondylolisthesis s/p fusion and scarlet fever age 18. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8729) via an unspecified route of administration on 06Apr2021 at 04:00 PM (at 56-year-old) on left arm as dose 1, single for COVID-19 immunization and experienced heart rate dropped to as low as 30. It was mentioned that no other vaccines were received in four weeks. The other medications in two weeks were reported as none. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. The allergies were reported as none. On an unknown date the patient reported inappropriate schedule of vaccine administered. The event resulted in disability or permanent damage. No treatment was received, and patient had not recovered.; Sender's Comments: Based on the information in the case, a causal relationship between inappropriate schedule of vaccination and suspect drug BNT162B2 cannot be excluded
Rec'd series of 3 vax given FEB90, MAR90, AUG90, was determined that he was a non-responder; no tx given; outcome pending; Reporter indicated vaccinee's non-response to the vaccine is permanently disabling;
Patient felt pain in arm, nauseous, light headed, warm and anxious 2 hours after receiving vaccinations. Patient went to ER and was given lorazepam, Ibuprofen, and zofran during ER visit.
For about 24hrs: Constant heart rushing >108BPM. Feeling faint, dissociated, cognitively slowed. Splitting headache, with fever of 101.2°F. Pain, soreness, and stiffness in both hips in all positions.
herpes zoster; post herpetic neuralgia; Information has been received from a lawyer referring to a patient of unknown age and gender, regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition.As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia was considered as not recovered and causal relationship was assessed as related.  Both events herpes zoster and postherpetic neuralgia were considered as disability by the lawyer.
maternal vaccine exposure with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30 years old female patient who was at 17 weeks of pregnancy and was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] during second pregnancy trimester.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was reported as 13-May-2023. The estimated due date is 17-Feb-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had <<XX>> previous pregnancy/ies.   On 13-Sep-2023, the pregnant patient received with unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (expiry date, strength and lot number not reported) via intramuscular route in unknown administration site as prophylactic vaccination (maternal exposure during pregnancy) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
My left arm was sore starting a few minutes after the vaccine. This soreness last through that night. When I woke up the next day, my arm was extremely sore and I was very dizzy. Additionally, my pulse felt fast but my heartbeat seemed to have less strength. My breathing felt more shallow like I wasn't getting as much oxygen from the air that I breathed in as I should. For the first two weeks, the dizziness was very strong. Now, at the three-week mark, it is more manageable and life is somewhat returning to normal. I visited an ENT doctor and their diagnosis was that my dizziness was not being caused by a preexisting medical condition.  Their prediction was that I would be fine, though looking back, I downplayed the severity of my vertigo. At its worst, I felt that, when I went for a walk outside, the surface was the Earth was violently spinning through space, with me stuck to the surface. It felt paralyzing. My body felt almost stuck in shock. I was afraid I would be stuck with this dizziness for the rest of my life since it was so long-lasting. Now, I am taking ginger pills and am watching my sodium intake. I feel better but am extra vigilant about taking ginger and not stressing myself too much. I do not plan on getting a second shot since some of my symptoms mirror those of anaphylaxis.
This case was reported by a consumer and described the occurrence of swelling arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching were unknown. It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, feeling abnormal and injection site itching to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient presented with similar symptoms after vaccination with SHINGRIX. This case was linked with case US2018GSK216507 and US2018GSK216504, reported by the same reporter.
Took varicella vaccine on 4/30/01. Broke out with varicella rash on 5/10/01. (Blister rash over head, trunk, face and extremities).
Wearing off effect; Total knee replacement; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4183195-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1152115) at cf for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 07Oct2021, outcome "unknown", described as "Total knee replacement"; THERAPEUTIC RESPONSE SHORTENED (medically significant), outcome "unknown", described as "Wearing off effect". The action taken for adalimumab was unknown.  Causality for Humira(Adalimumab)The reporter's causality for the event(s) of left knee replacement and not lasting entire injection cycle/Humira effects seemed to mildly wear off a little before next Humira injection was not provided. Companyc's opinion is that there is no reasonable possibility that the events of left knee replacement and not lasting entire injection cycle/Humira effects seemed to mildly wear off a little before next Humira injection are related to Humira(Adalimumab).  The reporter considered "total knee replacement" and "wearing off effect" related to bnt162b2.  Additional information: The patient had Right and left knee replacement on 07Oct2021.The patient stated that before next injection that the effect seemed to mildly was wear off. The patient did not stopped Humira for either operation. Doctor said that to patient should stopped Humira but her gastro physician was not okay with stopped Humira.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events "total knee replacement" and "wearing off effect" 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
shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received Shingrix. On 10th September 2019, 1 hr after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for the case for herself. The patient received dose of Shingrix in the right arm last night. About an hour later, the patient experienced shoulder pain. On the day of reporting, the patient called, seeking treatment recommendations but was referred to a health care provider. The patient stated that, pain had gotten worse over the night. The health care professional did not asked. This case was linked with the case US2019165574, reported for patient's husband.
Rash on lower arms and lower legs the day after injection X 5 days. 2 days, post vax, knees and elbows stiff X 1 1/2 days. On the 3rd day, post vax, fingers, ankles and feet swollen which lasted a couple of days. Notified MD. Pt refused treatment of cortisone. Took Tylenol for aching. No symptoms after 1 week.
NURS- Registered Nurse Specialty:  Registered Nurse Nursing Note Addendum Encounter Date:  6/16/2021     Addendum        Hide copied text  Hover for details Patient  61 y.o. year old   Date of incident: 06/16/21 Time of incident:  16:16 Pertinent patient history:  History of anaphylaxis to multiple medications and foods (none to any components of the COVID-19 vaccine) Description of incident:  Following administration of COVID-19 vaccine, patient experienced congestion/stickiness in throat, some coughing and reported sensation of tightness in the throat. She also began dry-heaving.   Initial Vitals at 16:17 Blood pressure:  162/74 Pulse:  104 Respirations:  22 O2 saturation:  99   Actions taken:  Provider summoned, 25 mg IM Benadryl administered per provider orders. Nurse came and administered Solumedrol 10 mg and EpiPen per provider orders.   Orders initiated per RN protocol: EpiPen administered per protocol, by RN, IM Benadryl administered per protocol by this writer, IM Dexamethasone 10 mg administered by MA.     Patient outcome:  Patient reported improvement in nausea although she continued to experience the sensation of congestion/tightness in throat.   Re-Check of Vitals at 16:23 Blood pressure:  120/82 Pulse:  90 Respirations:  20 O2 saturation:  99     Patient left vaccine clinic via Patient Transport: Ambulance: EMS Called by  MA at at 4:27 PM   Other notes: Provider who evaluated patient suggested that patient be premedicated with steroids and Benadryl prior to next vaccine.   RN ....................  6/16/2021   4:54 PM
I started out with a sore neck about 12 hours after the injection.  As the day went on, fatigue, severe joint pain, general achiness set in.  As the day went on I experience brain fog, chills and occasional dizziness.  24 hours after the injections I experience severe chills and night sweats.  36 hours after the injection, most of the pain subsided, but slight fatigue and brain fog remained.  I took Tylenol the help with symptoms of pain soon after they began.
no additional adverse effects reported; adult patient was administered a pedatric dose; adult patient was administered a pedatric dose; This spontaneous report was received from a medical assistant regarding a 57-year-old patient. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 04-FEB-2014, the adult patient was administered a pediatric dose of Hepatitis B vaccine (Recombinant) (thiomersal-free) (RECOMBIV AX HB ) 5/0.5 microgram/milliliter, lot J006681 and expiration date: 05-DEC-2015 and again on 27-OCT-2014, a pediatric dose of Hepatitis B vaccine (Recombinant) (thiomersal-free)(RECOMBIV AX HB) lot 1014855, expiration date 16-APR-2016 (route of administration was not reported) was administered by another clinic (incorrect dose administered). No additional adverse effects were reported. No product quality complaint (PQC) was involved.
Swelling in throat and difficulty breathing. Called 911 and administered Epipen 0.3mg , patient feeling better by the time the EMT arrived. Patient was taken to hospital for further evaluation and treatment.
Numbess/tingling all through right arm, still ongoing.  Some days not very much, some days its more noticeable.
pt stated he took 2 Tylenol and went to bed the day of the vaccine.  He had a poor night of sleep.  The next day his legs became very weak (like jello) so had trouble keeping balance or walking.  They called  the ambulance.  His vitals were normal.  He was transported to hospital.  Upon arrival to ER his speech was slurred but after being there for about an hour he felt as is he was getting back to normal. He had a CT scan and bloodwork.  He was released and able to drive home.  The next day he felt like he was getting back to normal.   He will FU w/ Neurologist next week.