chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around the beginning of August I began having itchy skin mostly on my arms and legs. If I scratched it it got red and sometimes it had welts (hives?).   This was mostly on my back or butt.  It goes away pretty quickly with Benadryl.    I emailed my dr and she prescribed a steroid cream and Seroquel.  The cream works, but the Seroquel  didn?t do much.  I started Zyrtec an d it helps.    The condition is better though I have some itchy days.   I didn?t see my dr in person, only contacted her by email.
Hives over chest. then over next 7 days it spread to abdomen, back, left forearm and back of my neck; Minimally itchy; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 54-years-old) as Dose 1, single for COVID-19 immunisation. Medical history includes high cholesterol from an unknown date and COVID-19 (diagnosed prior to the vaccination). The patient had no known allergies. Concomitant medications included lovastatin (MANUFACTURER UNKNOWN), via unspecified route of administration from unknown date to unknown date at unknown dose and frequency for an unspecified indication; acetylsalicylic acid (ASPIRIN), via unspecified route of administration from unknown date to unknown date at unknown dose and frequency for an unspecified indication; famotidine (MANUFACTURER UNKNOWN), via unspecified route of administration from unknown date to unknown date at unknown dose and frequency for an unspecified indication and gummies vitamins, via unspecified route of administration from unknown date to unknown date at unknown dose and frequency for an unspecified indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Apr2021 at 08:00, day 2 after the vaccine, the patient experienced hives over chest, then over next 7 days it spread to abdomen, back, left forearm and back of her neck and was minimally itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with diphenhydramine hydrochloride (BENADRYL) at home once which had no effect. The clinical outcome of the events hives over chest and minimally itchy were recovering.  No follow-up attempts are needed. No further information is expected.
MMRV was given instead of MMR at the same time Varicella was given by mistake.   No adverse reaction noted at this time. Mother states Patient has been fussy with low grade fever. She has given tylenol and motrin as need.
Information has been received from a healthcare worker concerning an approximately 12 month old (reported as "one-year-old") female patient with mold allergy and no pertinent medical history who on 30-MAY-2012 was vaccinated SQ with a 0.5mL dose of MMR II (lot #: 671485/1450AA, exp. date: 30-SEP-2013) by a physician. There was no concomitant medication. On approximately 06-JUN-2012 the patient experienced a rash and fever. There was unspecified treatment for the adverse events. No lab diagnostics studies were performed. The patient sought unspecified medical attention. The healthcare worker reported that the patient might had recovered from the events, but she was not one-hundred-percent sure. Follow-up information has been received from a physician concerning a 13 month old female patient with no illness at time of vaccination who on 30-MAY-2012 was vaccinated with the first dose of MMR II (lot # 671485/1450AA), 0.5 mL), the first dose of VARIVAX (Lot# reported as "1912AA") and the fourth dose of PREVNAR 13 (Lot# 917243). On 06-JUN-2012 the patient experienced irritable and fever. On 11-JUN-2012 the patient broke out in a rash. Spotty blotches all over body for about a day or two. At the time of reporting, the patient recovered. Additional information is not expected.
Menses onset 2 days after, 21 day cycle; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was 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 16May2021, the patient had menses onset 2 days after, 21-day cycle. The event did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of this event. The clinical outcome of the event menses onset 2 days after, 21-day cycle was recovered on an unspecified date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
In the months following my original 3 Moderna mRNA vaccination events, I experienced a delayed worsening of my chronic idiopathic urticaria, and renewed, persistent HSV flares on the skin of my face and in both eyes. 18 days after receiving my Novavax dose (last mRNA booster was October 2021), on 30 Oct 23, I also received an RSV vaccine (Abrysvo). Approximately 9 days after receiving the RSV vaccine, I began to experience a severe increase in my chronic idiopathic urticaria (CIU), similar to what I had experienced after prior mRNA covid vaccine injections. Yesterday, 13 Nov 23, I also developed a large herpes lesion on the lower right side of my chin, also similar to flares I began to experience after the initial mRNA vaccines. Because I received 2 different vaccines with only ~2-1/2 weeks in between, I know it's not possible to confirm that one or the other caused the adverse effects with any certainty, but I'm reporting on this page for the covid vaccine because the side effects mirror what I had experienced previously with the mRNA vaccines, and a few days ago, I also reported the increase in hives through the V-Safe check-in for the RSV shot I received.
a high grade fever; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 15:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 76 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: She has rheumatoid arthritis (RA) and on she is on an immune suppression drug Orencia. She was diagnosed with RA before receiving COVID-19 vaccines and about 26 years ago; "Diabetic" (unspecified if ongoing), notes: Comments: Diabetic. Concomitant medication(s) included: ORENCIA taken for rheumatoid arthritis. Vaccination history included: BNT162b2 (Dose: 1, Date given: 30Jan2021, Manufacturer: Pfizer, Lot: EL9253, Expiration: Unknown, Dose given: Unknown, Time given: Unknown), administration date: 30Jan2021, when the patient was 74-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, Date given: 21Feb2021, NDC: Unknown, Lot: GL9267, Expiration: Unknown, Dose given: Unknown, Time given: Unknown), administration date: 21Feb2021, when the patient was 74-year-old, for COVID-19 Immunization; Moderna (Dose: 3, Date: Dec2021, Manufacturer name: Moderna), administration date: Dec2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 11Sep2022 at 09:30, outcome "unknown", described as "a high grade fever"; HYPERHIDROSIS (non-serious) with onset 11Sep2022 at 09:30, outcome "unknown", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Chills and rigors. Temperature >101°F for 72 hours with ibuprofen treatment. Headache for a week after.
This is a report for an administration error.  This patient received a dose on 3/11/21 and inadvertently received another dose on 3/15/21.  There were NO ADVERSE EFFECTS NOTED.  Per the Moderna information, this early second dose is considered invalid, but there is no indication to give a repeat dose.
Fluzone.  There was no adverse event more than slightly fussy, small swelling, and an Arthus reaction.  It was on the left thigh, where we also gave Pentacel, so it's hard to say which caused the reactions.  However, since it was given two months early, I felt compelled to report.
had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted.; This non-serious case was reported by a physician via call center representative and described the occurrence of intercepted product storage error in a an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient did not receive Rotarix lyophilized formulation, Bexsero, Menveo, Engerix B, Havrix, Kinrix, Infanrix and Pediarix. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, Bexsero, Menveo, Engerix B, Havrix, Kinrix, Infanrix and Pediarix, the patient experienced intercepted product storage error (Verbatim: had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted.).  The outcome of the intercepted product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-AUG-2023 The health care professional called to inform that Bexsero, Engerix-B, Havrix, Infanrix, Kinrix, Menveo (2-vial), Pediarix, Rotarix (Liquid presentation) had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted. Due to technical limitations in the system, they could not ensure the vaccines were viable, so they had to be discarded, which led to Intercepted product storage error.  Prior to this decision, some vaccines were administered to patients. At the moment of the call health care professional did not have a number of patients or the vaccines they were given. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case has been linked to the case US2023AMR119110 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR119110:
pt seemed to have a focal seizure while sitting in the waiting area within 5 minutes of vaccination... followed by a period of lethargy and incoherence /. pt vomited while getting onto the stretcher .
Since the first night,  fever and chills, that continued for 6 days,  started nonstop coughing on the 7th day, started having diarrhea on the 8th day and is still continuing today which is his 9th day. He has been taking cold medicine now cough medicine and cold and sinus pills?
Patient was inadvertently administered Pfizer orange cap (10mcg) for second dose instead of Pfizer maroon cap (3mcg).   CDC was contacted immediately to get recommendations.  Situation was discussed with Dr. and parents were notified.  Patient was not having any side affects or adverse reactions.
Rheumatoid arthritis pain in arms and legs/Arthritic pains; Vaccination related malaise; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain in arms and legs/Arthritic pains) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No relevant history was reported.  Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain in arms and legs/Arthritic pains) (seriousness criterion medically significant), IMMUNISATION REACTION (Vaccination related malaise) and CHILLS (Chills). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain in arms and legs/Arthritic pains), IMMUNISATION REACTION (Vaccination related malaise) and CHILLS (Chills) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The formulation for co-suspect product Humira was reported as Solution for injection in pre-filled pen.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of MODERNA CAUSED CHILLS AND MADE FELT SICK unknown, MODERNA CAUSED CHILLS AND MADE FELT SICK unknown and RHEUMATOID ARTHRITIS PAINS IN ARMS AND LEGS was not provided.  No treatment medications were reported.  Company comment- This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, serious (medically significant) AESI Rheumatoid arthritis which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient reported that after vaccination with mRNA-1273, she experienced chills and felt sick. She also noted arthritic pain in the arms and legs. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, serious (medically significant) AESI Rheumatoid arthritis which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient reported that after vaccination with mRNA-1273, she experienced chills and felt sick. She also noted arthritic pain in the arms and legs. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a female consumer of unknown age refers to herself. The patient was vaccinated with 1 injection of ZOSTAVAX under the skin (date, dose and lot # unknown). No other co-suspects were reported. No concomitant medications were reported. The patient called and reported getting ZOSTAVAX after having the shingles. She added that she got a 2nd episode of the shingles on an unspecified date after getting the ZOSTAVAX. The patient sought an unspecified medical attention. The outcome was unknown. Additional information is not expected.
Information has been received from a physician concerning four female patients who were vaccinated with doses of GARDASIL. Subsequently the patients experienced postural hypotension. Unspecified medical attention was sought. At the time of this report, the outcomes were unknown. Follow up information was received from a physician on 26-MAY-2009. The patient was the pharmacist's daughter. The physician stated that after further discussions, it was decided that there was no relation to these events and the GARDASIL vaccination. The physician was confident that the patient was fine. This is one of several cases from the same source. No further information is available.
asthenia; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (asthenia) and COVID-19 (Covid-19) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 immunisation.    Co-suspect products included non-company products NVX COV 2373 for COVID-19 immunisation and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 immunisation.    Concurrent medical conditions included Pancreatitis relapsing, Diarrhoea, Peptic ulcer and Unevaluable event.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, dose of NVX COV 2373 (Intramuscular) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Aug-2022, the patient experienced ASTHENIA (asthenia) and COVID-19 (Covid-19). At the time of the report, ASTHENIA (asthenia) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It has been reported that patient presented to ED for increased weakness for 1 week.  The causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events was considered Possible.  Treatment information was not provided.
Joint pain, body aches, loss of appetite, and sharp pain in left arm (could not lift arm for two days).  Fever of 100 within 12 hours of injection.  Fever went up to 102 and remained at that level for about 46 hours.  Total recovery time was three days.
6-1-07 Parent called-Arm red and swollen and warm to touch. Advised by phone will recheck if desire. 6-2-07 Parent called-Arm same-Now with joint pain and neck still-Biaxin 250mg bid x 7 days.
Information has been received from a office manager, concerning an 17 year old female patient with mononucleosis diagnosed in the beginning of April 2008. On 14-APR-2008, the patient had a recheck for the mononucleosis. On 16-APR-2008, the patient was vaccinated with the first dose of GARDASIL (Lot #14870) and MENACTRA. The patient experienced feeling sick and fainted immediately after the vaccinations. The patient also experienced a lot of bruising on an unspecified arm within 24 hours of the vaccinations and her hair was falling out (unspecified date). The patient recovered on an unknown date. The patient sought medical attention in the office and called the office. There was no product quality complaint. Follow up information was received from the physician's office and laboratory records concerning a 17 year old white female with infectious mononucleosis (recovering; last day re-checked on 14-APR-2008 and "she was ok") and an allergy to sulfa who on 16-APR-2008 was vaccinated with a first dose of GARDASIL into the right arm and with a first dose of MENACTRA (Lot # U2542AA) into the left arm. In between 16-APR-2008 and 31-JUL-2008, the patient complained about sweating, shaking, vomiting and being extremely sore all over. On 14-APR-2008 the patient underwent a hepatic panel and complete blood count which revealed an elevated liver enzymes which were noted to be "improving." (refer to lab data field). On 31-JUL-2008 the patient had a thyroid stimulating hormone and free thyroxine level and CBC. The TSH was low at 0.30 uIU/mL (nl 0.50 - 5.20) and the FT4 was normal 1.1 ng/dL (nl 0.8 - 1.8). The MCH and MCHC were low. (refer to lab fields). On 08-MAY-2008 patient developed canker sores treated with FAMVIR. On 31-JUL-2008 the patient developed hair loss (checked with Blood work) and was bruising easily. The patient had recovered on an unknown date. Additional information is expected.
Patient received PFIZER COVID vaccine at approximately 1100.  Reported history of itching and tightness in throat after dose #1 and dose #2 (did not disclose on screening form). Patient pre-medicated with children's Benadryl (reports she is allergic to the dye and some medication coatings).  11:23 patient reported itching in throat, given water and taken to exam room. patient reported "feels like water is getting stuck". Last Benadryl 11:15AM. Declined IM Benadryl. 11:30 BP 115/80, O2 99%, HR 65- no obvious airway swelling or malformation Patient talking and conversating normally, no respiratory distress, wheezing or stridor. 11:38 BP 121/86, O2 99%, HR 64 11:40 Feels better, requesting to go home.
Patient reports that on Wednesday, 09/19/2012, he was given two vaccinations in the right deltoid. The first vaccination was a flu vaccine and the second vaccination was a Pneumovax. Patient reports that he developed erythema, excess heat, and swelling in the deltoid. Patient reports that the erythema has now spread from the deltoid across the arm and into the axillary area. In addition, there are streaks noted down the arm. Patient states that the area is painful to touch, and he is not able to sleep on the right side. Patient states that he has had a flu shot before and never had a reaction. Patient has not previously had a Pneumovax. Patient denies difficulty moving the arm. Patient denies fevers/chills.  1. The area of erythema as outlined, and the patient is advised that if the redness spreads beyond the lines, then he is to start Bactrim DS one p.o. b.i.d. x 10 days. Patient is advised of the side effects of this medication. 2. The nurse manager has been notified and has also reviewed the reaction and will do the appropriate reporting. 3. Patient advised when to seek emergent care. Patient is also advised to use ice packs on the muscle. 4. Patient advised to follow up as needed for this issue.
Came down with bad head cold nasal congestion, cough and weezing. Also a rash similar to poison ivy all over my neck, both arm and body.
Two days after her second Moderna vaccination (administered on 2/25/2021) she developed lesions on her neck.  We took her to an urgent care clinic on 3/2/2021 and they diagnosed her with a shingles outbreak more than likely as a result of her vaccination.  She did not have any reaction to her first Moderna vaccination four weeks earlier.  She was prescribed an anti-viral.  She is more comfortable now but her cognitive and physical abilities have declined significantly.  She is also having significant sleep issues which have also contributed to her cognitive and physical problems.
Headaches, rash, muscle aches, sinuses, memory loss, joint aches. These symptoms started in body after I returned (plus skin spots).
On 09/02/2020 around 230 pm Patient was back at our office stating that she had a itchy tongue and lips, swollen tongue, difficulty swallowing.  I asked Pt when these Sx started and she said they started at about 1:15pm or so after she had eaten lunch.  Upon examination by Staff no apparent distress and noted to have mild edema to lower lip and tongue.  Lungs clear and equal bilaterally.  Heart rate regular rhythm with good perfusion.  Normal blood pressure.  Ordered epi and benadryl stat, called 911 to transport to hospital for continued monitor should rebound reaction occur.
Chills, Fatigue, Muscle Weakness, Rapid Heartbeat, all overnight for approximately 12-15 hours
Redness & swelling of rt arm following immun 27JAN92; tx w/moist heat & Motrin for local rxn;
January 21 - began menstrual / vaginal bleeding (I have been menopausal for 20 years), this lasted 48 days thru March 7.  Bad cramps on Feb 2.      Visited my Gyn, Dr.  He did saline sonogram 2/22/21 then biopsy of uterus on 2/24/2021 to rule out gynecological issues.  Negative.     Additionally around February 10th - dark red, blood  "splotches" appeared on both lower legs.  Did not disappear until end of March.   Visited my dermatologist Dr,  regarding these splotches.   He had no explanation.