chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A lot of Hives; Skin is hot; Skin is burning; Itchy Hives; May have Keratosis Pilaris; Second dose > 2 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A lot of Hives), FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives) and KERATOSIS PILARIS (May have Keratosis Pilaris) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced URTICARIA (A lot of Hives), FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives), KERATOSIS PILARIS (May have Keratosis Pilaris) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose > 2 months after first dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 UNK; LORATADINE (CLARITIN [LORATADINE]) at a dose of UNK dosage form; HYDROXYZINE HCL at a dose of 25 mg once a day and CLOBETASOL PROPIONATE at a dose of 60 gram. On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose > 2 months after first dose) had resolved. At the time of the report, URTICARIA (A lot of Hives) had not resolved and FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives) and KERATOSIS PILARIS (May have Keratosis Pilaris) outcome was unknown.            No concomitant product use was provided by the reporter.  Treatment medications included she visited several doctors and used Benadryl, Claritin, Hydroxyzine HCL 25 mg tab once daily and Clobetasol Propionate ointment O.5% 60 gram (does not use every day).   This case was linked to MOD-2021-315268 (Patient Link).
got real sick; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got real sick), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got real sick), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, ILLNESS (got real sick), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medication were reported. No treatment information was provided by the reporter.  The patient got real sick: fever, headache, and chills for a day.
PT CALLED TO REPORT ITCHING REDNESS, SWELLING AND RASH AT INJECTION SITE. ADVISED COLD COMPRESS, ANTIHISTAMINE AND TOPICAL HYDROCORISONE IF ITCHING DIDN'T RESOLVE AND TO CALL BACK TOMORROW.
SHAKING; NUMBNESS BOTH ARMS; PAIN AT INJECTION SITE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced shaking. On 05-MAR-2021, the subject experienced numbness both arms. On 05-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. he batch number was not reported and has been requested. The patient was recovering from shaking, pain at injection site, and numbness both arms. This report was non-serious.
I am a breastfeeding mother and do not get periods while breastfeeding. After the shot I got hormonal acne, not ideal but I can deal with it. Today my period just unexpectedly started. I  am still breastfeeding so this is not great. Breastfeeding may not be able to continue with the return of my period so this is a huge deal for me and likely other women.
poor quality vaccine administered; states that their refrigerator with vaccines previously experienced a temperature excursion that reached 37.2C and the vaccines were deemed not suitable for use with no reported adverse event; Initial information received on 07-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 11 years old female patient who experienced states that their refrigerator with vaccines previously experienced a temperature excursion that reached 37.2c and the vaccines were deemed not suitable for use with no reported adverse event and poor quality vaccine administered while receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (dip tox) (menactra) for Immunisation.  On 07-Jun-2022, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U7283AA; expiry date: 02-Feb-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On 07-Jun-2022 the patient reported refrigerator with vaccines previously experienced a temperature excursion that reached 37.2c and the vaccines were deemed not suitable for use with no reported adverse event (product storage error) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine. On an unknown date the patient developed a non-serious poor quality vaccine administered (poor quality product administered) (unknown latency) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01135750:
Around noon left arm became sore around injection site; at 9 p.m. 11/27/18 I felt suddenly nauseated, my scalp was sensitive, I had chills and a fever of 100.4. My hands were cold and fairly stiff.  Stretching them out required special effort. Felt dizzy at 2 a.m. 11/28/18 temperature was 100.6, all other symptoms remain except the scalp sensitivity. Slight headache.
This case was reported by a healthcare professional and described the occurrence of fever in a 5-year-old female subject who was vaccinated with PEDIARIX, IPOL. Concurrent vaccination included HIB vaccine and PREVENAR both given on 10 July 2003 and live MMR II given on 6 August 2008. There were no concurrent medications. On 6 August 2008 at 15:00 the subject received unspecified dose (it was noted to be the subjects 5th dose of PEDIARIX at 0.5 ml in the left thigh. Also on 6 August 2008, the subject received 4th dose of unspecified time after vaccination with IPOL, the subject developed fever and heart palpitations. These events resolved within 24 hours of onset, 8 August 2008. The subject also experienced an accidental overdose as she received an extra dose of IPOL. The healthcare professional considered the events were probably related to vaccination with PEDIARIX. When the subject had been asked if she had any previous events with other vaccines, it was reported that the subject developed a fever after receiving 1st dose of PEDIARIX (lot number was 21883B2 or 21881C9) in the left thigh on 10 July 2003. The fever resolved within 24 hours. It was reported that the subject had received both of the lots given above, but the reporter was unsure which one specifically was given for the 1st dose. Follow-up information received on 06 October 2008 indicated that the events resolved and were not considered to be related to treatment with PEDIARIX, but related to inactivated IPOL.
I woke up about 3 AM with uncontrollable shivering which lasted for about 10 minutes. It went away after I turned the thermostat up and bundled up. I have never had this happen before.
Information has been received from a physician's assistant concerning a 4 year old female who on 20-DEC-2004 was vaccinated with the first dose of VARIVAX (Oka/Merck). No reaction was reported after the first dose. On 04-AUG-2008 the patient was vaccinated with the second dose of VARIVAX (Oka/Merck). Subsequently the patient had a rash and small pin size blisters at the injection site. The patient's outcome was unknown. The patient contacted physician's assistant. Additional information has been requested.
Patient with a history of syncope after injections of any kind.  Afraid of needles. Approximately 7 minutes post injection patient passed out in observation.  LOC less than 20 seconds.  Awake and oriented x3 and VS stable and within normal limits.  Dr. , medical director, consulted.  No further orders. Observed for 30 minutes and wife called.  Patient released to self.  He will bring a driver for dose 2 and let staff know he has syncope with injections.
dizzy since I got my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy since I got my first vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy since I got my first vaccine). At the time of the report, DIZZINESS (dizzy since I got my first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment and concomitant drugs information was not provided.
Left upper arm 9cm inflammation, 2 cm induration darker red in center where induration is located.
Redness, swelling, fever. Tylenol q 4 hours. Cool pack to leg q 4 hours. RTC PRN if necessary.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   It is unknown if the patient experienced any additional symptoms/events It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Report A0359048A describes Lyme disease in a 37 year old female who received Lyme disease vaccine recombinant OspA. This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. The medical history included allergy to Paxil and Lamictal, manisfested by a "severe" rash. The vaccinee had a "long history" of bipolar disorder requiring hospitalizations for periods from three days to two weeks, sometimes as frequently as every six months, since 1993. She also had anxiety and insomnia. As of 2/1/02, she was being tested for hypertension. She had arthritis with aching knees since age 20. The vaccinee stated that she had no history of gout, psoriasis, or Crohn's disease. There was no family history of lupus. Reportedly, her paternal grandfather and his seven sisters had an unspecified form of arthritis. Concurrent medications included lithium and phenilzine sulfate (Nardil) for treatment of bipolar disorder, Valium for treatment of anxiety, and Ambien for treatment of insomnia. In April 2000, the vaccinee reportedly received her first injection of LYMErix without adverse event. The vaccinee stated that in June 2000, she received her second injection of LYMErix. She reported that, on 7/5/00, she experienced auditory and visual hallucinations. She was hospitalzied on 7/5/00 or 7/6/00. It was reported that her hospitalization lasted three months. The vaccinee stated that by November 2000, she experienced exhaustion, blurred vision, muscle pains, irregular sleep patterns (she sometimes was only able to sleep one to two hours in a three-day period), irregular menses cycle (every two weeks), and unstable blood pressure (varied from "very low to very high.") She also reported that she developed "high" white blood cell counts. She stated that she was tested for Lyme disease by her psychiatrist in January 2001, and the test was "positive." She was seen by an infectious disease specialist in March 2001. On 3/14/01, Lyme total antibodies by ELISA were elevated. Lyme IgG Western blot reportedly demonstrated a 30kD band. A diagnosis of Lyme disease was reportedly made, and the vaccinee was treated with IV Rocephin for one month beginning in March 2001. On 4/3/01, Lyme IgG Western blot again reportedly demonstrated a 30 kD band. An unspecified test for syphilis was "mildly reactive." Rheumatoid factor and an unspecified anti-DNA test were "negative." On an unspecified date in 2001, Lyme IgG and IgM Western blots each demonstrated a 41KD band. She reported that she was tested for cat scratch fever on an unspecified date in 2001. B. henselae IgG was "256" and B. quintona IgG was "256." On 1/18/02, Lyme IgG Western blot demonstrated 30 and 41kD bands. At that time, she reportedly was told that she did not have Lyme disease. The vaccinee stated that it "has been impossible" for her to work since receiving LYMERix injections. As of 2/1/02, the outcomes of the events were unknown. She reportedly did not have Lyme disease, but was still unable to work. The vaccinee declined to grant authorization for manufacturer to contact her physicians. Therefore, no further info will be available.
My side effects after taking the 3rd dose included: fever, chills, body aches, and headache. These symptoms lasted for 24 hours. I am also a breakthrough case. I started to develop symptoms for Covid-19 on 01/02/2022. My symptoms included a sore throat, chest tightness, cough, fever, chills, sweats, body aches, fatigue, and headache. My main symptoms lasted for 3-4 days.
Patient stated a body rash developed a few days after getting BOOSTRIX (unsure if related). Went to doctor and was prescribed a topical steroid cream.
Severe, total body shaking.  Sudden onset, occurred while lying in bed.  Approximately 20 minutes duration. Eventually subsided.
Pt recv vax on 11/16/98; on same day pt exp sore/ pain/ decreased mobility of LA & shoulder; tx=Ibuprofen, heat, ice
01/05/23 presents to ED for "abnormal labs" "shortness of breath". PMHx of "chronic anemia, diabetes, hypertension"
minor injection site reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (minor injection site reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (minor injection site reaction). At the time of the report, VACCINATION SITE REACTION (minor injection site reaction) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Began with a hive and itchy feeling in body. Then face became flush, noted hives on face. Then when taken to the hospital urgent care, airway constriction. Treatment: prednisone, diphenhyramine, ranitidine and at home when airway constriction reoccurred- ventolin.
Severe, debilitating stomach pain, weakness, nausea, diarrhea, headache.
Patient complained of SOB and "not feeling well"  BP 174/129  HR 133 Sat 98%   Repeat BP  178/130  HR 132 Sat 97%    Medical Emergency Team activated and took patient to ED to be evaluated
Headache, Arthralgia, FATIGUE, PAIN TO INJ SITE Narrative:
Caught influenza. Sick 4 days. Was I injected with live virus or no time to develop immunity? While sick I saw MD.
pt recvd vax & 2 hrs later convuls, duration 1 hr; to er, turned blue, resp & heart rate affected, stopped breathing; now sz disorder;
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # M037669, expiry date: 09-MAY-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-JUL-2016, the patient was treated for a vesicular outbreak, accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Mother of child states that the child had a rash on arms the day after receiving vaccine, that itched & some whelps. Mother applied OTC ointment, which has helped.
the night I got the shot, got shingles; the night I got the second shot got sick; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced shingles and sickness. On an unknown date, the outcome of the shingles and sickness were recovered/resolved.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the vaccine and the night he/she got the second shot, got so sick and got shingles so bad, was sick for 2 months. The reporter suggested not to get the vaccine. The follow-up would not possible as no contact details were available.
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. The reported stated that on an unknown date the unspecified patients received improperly stored (Oka/Merck) VARIVAX (lot # J013728 exp. Date: 30-OCT-2015 and lot # J009992 exp. Date: 12-AUG-2015, dose, route, indication not reported) and (Oka/Merck) PROQUAD (captured in MARRS # 1408USA008610) which were exposed to a maximum temperature of -9C on multiple occasions, for undetermined timeframe (also reported that both vaccines were exposed to only -8.9C for only 15 hours. No adverse effects were reported. No Product Quality Complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Drowsiness, shortness of breath, massive sinus headache, achiness; took Tylenol and Aleve.
Patient had febrile seizure within 12 hours of administering vaccines (MMR, Varivax, Influenza). Temp 104.7 in ER at hospital. Admitted for observation for 24 hours. Follow up 02/16/05: Possible shivers/chills, what sounds like a generalized tonic clonic seizure. The event taks place 9.5 hours immunization. Has a twin who who did not have adverse event. Information received from discharge summary states chills.