chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; fever; chills; body ache; i woke up with plugging of my nose; could not breath; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and RHINORRHOEA (i woke up with plugging of my nose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction to drug.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced RHINORRHOEA (i woke up with plugging of my nose) and DYSPNOEA (could not breath). On 23-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache), RHINORRHOEA (i woke up with plugging of my nose) and DYSPNOEA (could not breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and RHINORRHOEA (i woke up with plugging of my nose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction to drug.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced RHINORRHOEA (i woke up with plugging of my nose) and DYSPNOEA (could not breath). On 23-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache), RHINORRHOEA (i woke up with plugging of my nose) and DYSPNOEA (could not breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
The day following the vaccination, I had chills, dizziness and fatigue.  I was unable to attend work.  This lasted approx. 36 hours.
TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-900) was received from a consumer on 16-Apr-2019. It describes a 67-year-old elderly female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for typhoid vaccination.  Case report: The consumer took all unrefrigerated doses of Vivotif. The first dose was taken on 09-Apr-2019 and the last dose on 15-Apr-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Heart event stopped him from breathing; stroke; lack of air; This is a spontaneous report from a contactable consumer, the patient.  A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunization.  Medical history included nut allergy from an unknown date and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included zolpidem tartrate (AMBIEN) and doxepin (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 13:00, the patient experienced heart event that stopped him from breathing and the lack of air caused a stroke; all reported as life-threatening.  On 14Jan2021, the patient underwent lab tests and procedures which included COVID-19 test which was negative.  The patient was treated for the events which included being put on a ventilator and sedation.  The clinical outcomes of the heart event stopped him from breathing, lack of air, and stroke, were not recovered.
Patient got 2 vaccines in left arm : 2nd dose of twinrix and First dose of shingrix > As per Patient her left arm swell like a bloon and and her Torso was very painful , she had Headache without Aura , high fever
a 47 year old female was given a prescription by her physician for GARDASIL 9; No additional AE reported; This spontaneous report was received from a consumer referring to herself a 47 years-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included  divorced. Concomitant therapies were not reported. Previous drugs reactions or allergies were not reported.  On an unknown date, the patient was given a prescription by her physician for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (Product prescribing issue). No additional adverse event were reported
Patient called and notified me that she developed a dry rash, raised welts on her breasts, abdomen, and hips four days after receiving her FLUZONE QUAD shot. The first day, she only experienced a localized reaction (warm, swollen, sore right forearm). It started with hives under injection site. She denied taking any new meds or using any new soaps/lotions/detergents. She was a retired nurse so knew to go to ER if symptoms worsened.
The patient stated she experienced nausea and a fever the day after receiving Shingrix. The symptoms lasted for four days.
Screaming for 3 hours 36-40 hours post vax. Not eating well.
I had fever around 101.9, body aches, sore throat, and headaches. I had a rash on my forehead a few weeks after, like an open sore.
At approximately 1:00am, 6-7 hours after the the flu shot was given, I had a grand mal seizure.  The seizure happened while sleeping in my bed.  The force of the violent seizure caused me to posterior dislocate my left shoulder (same arm where the flu shot was given).  I also have multiple compression fractures of my thoracic spine from the seizure.  A petechiae rash was present on my left arm at the injection site spreading across my neck and face.  I have never had a seizure and have no family history of seizure activity.  The seizure was a reaction to the flu shot.
10-11 days, post vax, pt developed a rash typical of early stage varicella with about 70 lesions. The pt sought unspecified medical attention. No further information is available.
Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 11/03/2022.
This spontaneous report was received from a pharmacist referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 05-JAN-2017 the patient was vaccinated with an expired dose of M-M-R II (rHA) lot # K015374 with expiration date 18-SEP-2016 for prophylaxis (dose and route were not reported). No adverse effects were reported. A product quality compalint (PQC) was not involved. Additional information has been requested.
Patient was thought to be 16 and able to receive booster dose, but was actually not 16 yet
Extreme exhaustion/fatigue with severe body ache and neck pain onset at approximately 6:00PM, followed by head ache and migraine like symptoms impacting ability to function by 8:00PM. Sleep was attempted starting around 7:30-7:45PM, but not achieved. By this time abdominal pain and nausea were both present. At about 9:00PM patient began vomiting accompanied by diarrhea. Warm compress in combination with noise and light restriction helped with severe neck pain, but nausea and vomiting continued for at least 8 hours. At approximately 1:00 AM patient took an adult dose of diphenylhydramine HCl, generic brand to help with muscle aches and headache, immediately followed by vomiting. Patient has been unable to eat or drink without vomiting. At time of reporting, symptoms are still present. Plans to visit a doctor immediately should they worsen anymore have been made.
Later on 04/07/2015 at night she began to break out with these blister like bumps. She was covered. Head to toes.
Presented with chief complaint of frequent falls and black color stool patient was admitted for further management. patient did have a lengthy and complicated hospital course for over 15 day; pt also dx w/ acute hypoxic respiratory failure related to COVID-19 pneumonitis and tx w/dexamethasone Lovenox vitamin-C and zinc.  Patient was back to 2 L nasal cannula. D/C to SNF.
Darker and the skin under my arm feels rather rough; rash on neck; 2 or 3 itchy bumps on elbow; Tinnitus increased to 3 times; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (2 or 3 itchy bumps on elbow), TINNITUS (Tinnitus increased to 3 times), DRY SKIN (Darker and the skin under my arm feels rather rough) and RASH (rash on neck) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced RASH PRURITIC (2 or 3 itchy bumps on elbow), TINNITUS (Tinnitus increased to 3 times) and RASH (rash on neck). On 14-Jul-2021, the patient experienced DRY SKIN (Darker and the skin under my arm feels rather rough). At the time of the report, RASH PRURITIC (2 or 3 itchy bumps on elbow), TINNITUS (Tinnitus increased to 3 times) and RASH (rash on neck) outcome was unknown and DRY SKIN (Darker and the skin under my arm feels rather rough) had not resolved.            The patient reported that 12 to 16 hours after the 2nd dose of vaccine she developed rash again, 2 or 3 bumps on the elbow and on the neck she noticed a skin rash which was very fine wrinkle lines.  The patient reported that she had tinnitus which got increased to 3 times after receiving vaccine. The rash was 3 times bigger with the 2nd dose as compared to  the 1st dose.  The patient developed the same odd rash under the right armpit.  No concomitant information was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-060405 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: NNI received On 16-Jul-2021: Non significant email follow up received On 19-Jul-2021: Significant FU Appended (event Info updated)
Injection site pain  Runny nose Headache Rash (arms hands feet) Vomiting/stomach pain
This spontaneous report as received from an office manager via a company representative, refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/ allergies were provided. On unknown dates, the patients were vaccinated with PROQUAD INJ (lot numbers, dose and route not reported). No c0-suspect or concomitant therapies were reported. The office manager reported that the physician's office had stopped administering PROQUAD several years ago due to a higher incidence of the patients reporting and experiencing fever. NO patient details were provided. At the time of the report, the outcomes were not provided. Additional information has been requested.
Lethargic, body aches, low-grade fever and extreme lymph node swelling in left armpit approximately 3". Lymph node swelling took about two weeks to go away. Other symptoms subsided after four days.
Swollen lymphnodes in left armpit, neck, shoulder, 102.4 fever for a week & continuing, soreness in eyes, vomiting, dehydration
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (106 doses were administered from vials with lot number 030H21B from 23Mar2022 to 25Apr2022, but they just realized this lot number expired on 23Mar2022.) and NO ADVERSE EVENT (no AEs were reported) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 prophylaxis. No Medical History information was reported.    On 23-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (106 doses were administered from vials with lot number 030H21B from 23Mar2022 to 25Apr2022, but they just realized this lot number expired on 23Mar2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (no AEs were reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (106 doses were administered from vials with lot number 030H21B from 23Mar2022 to 25Apr2022, but they just realized this lot number expired on 23Mar2022.) and NO ADVERSE EVENT (no AEs were reported) outcome was unknown.    For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no AEs were reported) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (106 doses were administered from vials with lot number 030H21B from 23Mar2022 to 25Apr2022, but they just realized this lot number expired on 23Mar2022.).    No concomitant medications were reported. HCP stated that lot number corresponded to the primary series for adults. No treatment information was reported.
Varicella; otitis media - information has been received from a nurse practitioner concerning an 18 month old white female who on 04 May 2000 was vaccianted with the first dose of varicella virus vaccine live sc in the right arm lot 631779/1354J.  concomitant vaccinations included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) msd sc in the left arm lot 634232/1721J. POLIOVIRUS VACCINE ipol. alum potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxioid  (tripedia) and heamophilus b conjugate vaccine acthib .  On 14 may 2000 the patient developed less than  50 lesions on forehead, cheeks, trunk, and back, a low grade fever of 99.7 and cold like symptoms..  The reported indicated that the patient had no known exposure to wild type virus.  The patient sought unspecified medical attention.  follow up information received on 01 Aug 2000 from a physician indicated that on 14 May 2000 the patient was seen in the office for mild chickenpox (mostly on face and trunk).  it was noted that at the time of vaccination the patient had an upper respiratory infection and no fever.  at a later date, the patient was seen for otitis media and had cleared the lesions nicely.  No further information is expected.
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that 24 month old male vaccinee was inadvertently administered Fluvirin IM on 14Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200805.
received scheme, experienced shingles/suspected vaccination failure; shingles 7 times; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: Around 2019, the patient received complete scheme of Shingrix around 3 to 4 years ago from reporting, and that during that time frame the patient experienced shingles seven times. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. Event outcome for shingles was conservatively captured as recovered as per structural field of source document.
Patient reports with low grade fever and complaints of headache, chills, abdominal pan, weakness and joint pain.
2 days p/pt recvd shots, ran a fever of 104.9 ax; mom gave bath @ that time & APAP given; 7PM t103 & lethargic; went to MD next day, had T 103 R; MD felt it was unrelated to the vax & a virus; had runny nose;
no adverse event was reported; Nurse reported that VARIVAX was accidently administered via IM route to a patient.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 18-OCT-2022, the patient was accidently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot #W011626, expiration date: 06-APR-2024, administered via intramuscularly (IM) for prophylaxis (strength, dose, and anatomical site injection were not provided)(incorrect route of product administration). No additional adverse event was reported.
Initial case was received on 13 October 2010 from a consumer/patient. A 76 year old female patient received on 05 October 2010, a left deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number not reported). Within one a a half hours she experienced diarrhea, nausea and had the "shakes." The next day (06 October 2010), the patient developed a "generalized welt like rash that began on stomach and spread" and she also experienced muscle aches. The patient's pre-existing medical conditions included lung cancer and an allergy to antibiotics. Concomitant medications included LEVOXYL, "amlodipine", potassium, SYMBICORT, vitamins and calcium (CA) supplement. The patient had no adverse events following prior vaccinations. The patient was seen by a nurse practitioner on 08 October 2010 and treatment included prednisone. The symptoms were slightly better, but not resolved. Follow-up information received from a health care professional on 29 November 2010. The patient's FLUZONE HIGH-DOSE lot number was reported as U3610AA. The outcome remained not recovered. Follow-up information was received from a health care professional on 13 December 2010 reported that the patient's physician had no direct knowledge of this event. No further information was provided. The outcome remained not recovered. Follow-up information was received from a health care professional on 27 January 2011 reported that the patient received the vaccine at a private doctor's office and provided address identifiers. The outcome remained not recovered. Follow-up information was received from a health care professional on 24 February 2011. The patient's outcome was reported as recovered. Documents held by sender: None.
no adverse event; vaccines administered after temperature excursion.; es were administered IM (instead of SQ).; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date in 2022, doses of  varicella virus vaccine live (oka/merck) (VARIVAX) lot #U028164, expiration date: 09-SEP-2023; and doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot #U006596, expiration date: 01-MAR-2023 underwent a temperature excursion of 32.9 fahrenheit degrees during 28 hours and 39 minutes with previous temperature excursions.  On 15-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U028164, expiration date: 09-SEP-2023, administered intramuscularly (Subcutaneous injection formulation administered by other route) (strength, dosage regimen, and anatomical location were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter, lot #U006596, expiration date: 01-MAR-2023, administered intramuscularly (Subcutaneous injection formulation administered by other route) (strength , dosage regimen, and anatomical location were not provided) as prophylaxis. No adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2208USA008558: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699:
Mother states that on Wednesday 8/19/17 when she arrived home she notice patient had a quarter size reaction on the injection site. Mother brought patient in today 8/11/17 for blood work and informed us that the patients left arm had a rash were vaccines were administer on Tuesday 8/8/17. Reaction size: 13.5 x 12 cm.
pt devel local immed @ site of inject lt deltoid w/swelling, erythema, & welts; 5 mins p/inject hives/welts spread to abdo & back w/extensive itching/irritation a systemic react; applied ice to local area; site of inject;
The following day I had a fever over 101 and I had vomiting and diarrhea. My arm was sore like you will get with the flu shot.
Client hospitalized on 8/24/2021 with SOB, cough, low oxygen saturation. Submitter does not have access to any further medical records for this client. For any other needed follow up information, please contact HOSPITAL.
Pain and bruising in injection site (immediate and continuous as of 10:00PM 4/21/2021). Chills (started around 7:00PM 4/21/2021). Fatigue  (started around 7:00PM 4/21/2021).
Narrative:  Patient is a 70 year old male who received his 2nd dose of the monkeypox vaccine on 10/22/2022. After receiving the 2nd dose, an induration formed with hyperemia and itchiness at the injection site. He presented to the ED on 10/26/2022 because he noticed the development of right eye swelling (periorbital edema).